CTS-1027 in Interferon-Naive Hepatitis C Patients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for CTS-1027 in Interferon-Naive Hepatitis C Patients (NCT00925990), a randomized phase 2 study. The primary outcome is Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment.

2. Clinical Question

The registry’s brief summary says the study was intended to assess whether CTS-1027 alone or in combination with ribavirin was safe and effective in patients not previously treated with interferon. The posted arm descriptions identify two groups: CTS-1027 with ribavirin and CTS-1027 with placebo for ribavirin. Thus, the posted comparison concerns adding ribavirin to a CTS-1027 regimen, rather than a comparison of CTS-1027 alone with no study drug.

The main outcome is a change in blood HCV-RNA, also called viral load, expressed in log (IU/mL). The posted results report mean changes over the baseline-to-24-week timeframe. The central statistical question is whether the observed average change differed between the randomized groups and how much uncertainty surrounds that difference. The outcome is a laboratory measure; the registry record does not report a patient-centered clinical endpoint or longer-term follow-up result.

The posted results can describe the observed contrast in this trial, but they do not by themselves establish how the regimens would compare in other populations or under other study conditions. The record does not report a detailed protocol rationale for selecting the endpoint, a target difference, or a planned analysis strategy.

3. Trial Design

The registry lists this as a phase 2, randomized, quadruple-masked, parallel-group trial. Enrollment is recorded as 70. The two posted arms each list 35 participants: CTS-1027 plus ribavirin and CTS-1027 plus placebo. The trial status is completed. The start is recorded as 2009-06 and primary completion as 2010-05.

The parallel design means the posted comparison is between groups assigned to different regimens, rather than a within-person sequence of treatments. Random allocation is intended in general to make treatment groups comparable at the start, including with respect to factors that may affect outcomes. Masking can in general reduce the influence of knowledge of assignment on care, outcome assessment, or reporting. The registry identifies masking as quadruple, but who was masked is not reported in the registry record, so the exact masking roles cannot be described.

The recorded interventions are CTS-1027, ribavirin, and placebo for ribavirin. The arm descriptions indicate that both groups received CTS-1027, while the groups differed in whether ribavirin or its placebo was paired with it. Details such as the dose, schedule, duration beyond the outcome timeframe, adherence, and permitted concomitant treatments are not reported in the registry record.

The primary outcome is the mean change in HCV-RNA from baseline through 24 weeks of treatment. The registry also lists mean change in aminotransferases over the same timeframe as a secondary outcome. Two outcome measures are recorded, and one secondary outcome is posted. The registry does not report the original trial’s sample-size assumptions, the method of random sequence generation, allocation concealment details, or a complete account of analysis populations.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All patients receiving at least one dose of study drug were analyzed for safety.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Mean Change in HCV-RNA (Hepatitis C Virus Ribonucleic Acid) Levels From Baseline Through 24 Weeks of Treatment, measured over Baseline and 24 weeks.

The primary endpoint is mean change in HCV-RNA levels from baseline through 24 weeks of treatment, measured in log (IU/mL). HCV-RNA is the amount of hepatitis C virus ribonucleic acid measured in blood; the registry also refers to it as viral load. The endpoint is calculated as the log10 HCV-RNA level at week 24 minus the log10 level at baseline. A negative change therefore represents a lower measured level at week 24 than at baseline, while a more negative mean indicates a larger average decrease on this log scale.

Viral load is used as a laboratory measure of the amount of virus in blood. In general, a quantitative endpoint can summarize the direction and magnitude of change across participants, rather than reducing each participant’s result to a yes-or-no category. A mean also allows a direct comparison of average changes between randomized groups. These features make the measure useful for describing an early trial’s biological response over a stated treatment period.

The endpoint does not, on its own, describe symptoms, quality of life, complications, or outcomes after the 24-week measurement. The registry record does not explain the clinical threshold, if any, that would be considered important for this measure. It also does not report whether the primary endpoint was analyzed in every randomized participant or only a defined subset. The posted means should therefore be read as statistical summaries of the recorded endpoint, not as a complete account of patient experience or longer-term outcomes.

7. Results Posted in the Registry

• CTS-1027 + Ribavirin: mean -0.48 versus -0.12 on control; difference -0.36 (95% CI -0.66 to -0.06), standardized effect d = -0.56; z-test p = 0.019.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Mean Change in Aminotransferases From Baseline to 24 Weeks of Treatment

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • CTS-1027 + Ribavirin: mean -15.60 versus -16.50 on control; difference 0.90 (95% CI -25.04 to 26.84), standardized effect d = 0.02; z-test p = 0.946.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between CTS-1027 + Ribavirin and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists one secondary outcome: mean change in aminotransferases from baseline to 24 weeks of treatment. Its group estimates show changes in both arms, while the estimated between-group contrast is small relative to the uncertainty expressed by its confidence interval. The interval spans both negative and positive differences, and the unadjusted p-value does not indicate a clear separation between group means. This secondary pattern is not a close replication of the primary endpoint’s observed contrast.

The two outcomes measure different quantities: HCV-RNA is a viral-load measure, whereas aminotransferases are blood measures recorded in IU/mL. A difference in their statistical patterns is not inherently contradictory, because different outcomes can vary in different ways and may capture distinct aspects of the condition. The registry record does not report a biological model linking the two endpoints, so a mechanistic explanation for their pattern cannot be established from the posted information.

Secondary results generally carry less weight than a prespecified primary outcome when multiple outcomes are assessed, especially when the analysis plan and multiplicity strategy are not reported. In general, examining multiple outcomes increases the chance that at least one result will appear unusual by chance. An unadjusted p-value does not account for that possibility. The record reports one posted secondary outcome and no reported analyses, but it does not establish whether additional outcomes or comparisons were considered during the study or how the secondary outcome was prioritized.

The secondary result is therefore useful as descriptive context, not as a standalone confirmation or refutation of the primary comparison. It also cannot establish that the groups are equivalent: a wide interval can be compatible with a range of differences. Interpretation should account for the study’s limited enrollment, the uncertain analysis population for efficacy, and the absence of details about missing observations and multiplicity handling.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Mean Change in Aminotransferases From Baseline to 24 Weeks of Treatment

9. Statistical Interpretation

10. Statistical Methods Explained

Continuous outcomes are commonly summarized by a group mean and standard deviation. The mean describes the average measurement or change in a group. The standard deviation describes how spread out individual measurements are around that average; it is not the uncertainty interval for the mean. For the primary endpoint, the registry reports the mean change and standard deviation for each arm, then a mean difference between arms. The difference is expressed in the same outcome units as the group means.

What does the mean difference represent?

The posted comparison uses CTS-1027 plus placebo as the reference group and reports the contrast for CTS-1027 plus ribavirin. The estimate of -0.36 is the mean change in the ribavirin group minus the mean change in the placebo-for-ribavirin group. A negative value means the first group’s mean change was lower on the endpoint scale. Since the endpoint is calculated by subtracting baseline log HCV-RNA from week-24 log HCV-RNA, lower changes correspond to larger declines in the measured log level. This describes the direction of the observed contrast; interpretation as a causal effect also depends on trial conduct and analysis details.

What does the p-value tell the reader?

The reported primary p-value is unadjusted and equals 0.019. In general, a p-value describes how unusual results at least as incompatible with a specified no-difference model would be if that model and the assumptions of the test were correct. It is not the probability that the no-difference model is true, and it is not a measure of the size or clinical importance of the difference. The registry record does not report the full test specification or whether the analysis was chosen before looking at the results. The word unadjusted also matters when several outcomes or comparisons are examined: no correction for multiplicity is reflected in that p-value.

Why report a confidence interval?

A confidence interval gives a range of values compatible with the data under the interval method and its assumptions. In repeated use of a valid procedure, intervals constructed at a stated confidence level would cover the underlying parameter at the corresponding frequency. A single interval is not a guarantee that the true value lies inside it, and its width conveys more about precision than the p-value alone. The registry posts a confidence interval for the primary mean difference; its endpoints are on the negative side of zero. The confidence level and detailed construction method are not reported in the registry record.

Why do standard deviations matter?

The standard deviations describe variability among participant measurements. Greater variability generally makes a mean estimate less precise when the group size is held fixed. In general, a standard error measures uncertainty in an estimated quantity, such as a mean or difference, and is distinct from the standard deviation of participant outcomes. The posted comparison includes standard errors for the two group means, but the registry does not explain the exact analysis procedure used to obtain the official result. The posted standard deviations and sample sizes can help readers understand the scale of variability, but they do not reveal the shape of the individual outcome distributions.

Why can randomization help?

In general, random assignment reduces systematic differences between groups in expectation, making a comparison of outcomes more informative about the assigned regimens than a comparison of groups formed by participant choice. In a trial with limited enrollment, however, important baseline differences can still occur by chance. Baseline characteristics are not included in the registry entries, so balance cannot be assessed. Quadruple masking is recorded, but the identities of the masked parties and the practical implementation are not reported in the registry record.

What does the planning illustration mean?

The planning illustration uses the observed effect as its reference and applies the stated assumptions: a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Its rows consider 100%, 75%, and 50% of the observed effect, with separate estimates for 80% and 90% power. These calculations are illustrations based on the posted estimate, not evidence about how the original trial was designed. They do not establish that the original enrollment target was chosen using those assumptions. Smaller effects require more participants to detect with the same power under the same assumptions.

For the primary endpoint, the posted unadjusted mean difference is -0.36 and the posted p-value is 0.019. No discrepancy between a recalculated comparison and the sponsor’s analysis is flagged. The record does not report a comprehensive analysis plan, adjustment for covariates, interim analyses, or a sample-size justification. Those omissions prevent a full reconstruction of how all analysis decisions were made.

11. Confidence Intervals and Precision

The primary mean difference is -0.36 log (IU/mL), and the posted confidence interval lies entirely on the negative side of zero. This indicates that the range of values compatible with the interval procedure does not include no difference, while still allowing a range of possible magnitudes for the contrast. The interval endpoints are not repeated in this narrative; the posted interval should be consulted for their exact values. The registry record does not state the confidence level or the method used to construct the interval.

Precision concerns how tightly an estimate is determined by the available data, not whether the estimate is important or whether a regimen should be used. A narrower interval indicates greater statistical precision under the method’s assumptions; a wider interval leaves more uncertainty about the magnitude. In general, precision depends on the number of observed participants, outcome variability, and the analysis method. The primary groups each list 35 participants, and their reported standard deviations are 0.5 and 0.76. These summaries give context for the estimate but cannot replace participant-level information.

The secondary mean difference is 0.9 IU/mL, with a confidence interval from -25.04 to 26.84. That interval includes zero and values in both directions, indicating substantial uncertainty about the secondary between-group contrast. Its unadjusted p-value is 0.946. The contrast and interval should not be treated as proof that the groups are identical; rather, the available estimate is compatible with a range of possible differences.

Confidence intervals rely on statistical assumptions. The registry does not report checks of distributional assumptions, handling of missing measurements, or the detailed interval method. The available intervals therefore communicate uncertainty as calculated for the posted results, while the record leaves some aspects of their construction and robustness unexplained.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total events. They are illustrative calculations based on the observed effect, with equal allocation between the two arms, a two-sided significance level of 0.05, and a normal approximation. The effect targeted in each planning scenario is the stated fraction of the observed effect. The original trial’s own sample-size assumptions and justification are not reported in the registry record.

The 80% power column gives the estimated participants per arm for a planning scenario that has an 80% chance of detecting the specified effect under the calculation assumptions, if that effect is the true one and the test assumptions hold. The 90% power column gives the corresponding estimate for a 90% chance. These are design-planning quantities, not probabilities that the observed finding is correct. This is not observed power.

For the primary outcome, planning for 100% of the observed effect gives 51 participants per arm for 80% power and 68 participants per arm for 90% power. Planning for 75% of the observed effect gives 90 participants per arm for 80% power and 120 participants per arm for 90% power. Planning for 50% of the observed effect gives 201 participants per arm for 80% power and 269 participants per arm for 90% power. The progression illustrates the general relationship: smaller effects need more participants to detect with the same target power, assuming the other planning inputs stay fixed.

These figures should not be read as a reanalysis of the original enrollment decision. They are computed from the effect observed in this trial, which is itself uncertain and may be an overestimate or underestimate of the underlying difference. They also do not account for information not stated in the assumptions, such as missing outcomes or any adjustments the original investigators may have planned. The registry record does not report that these calculations informed the design.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -0.360; pooled standard deviation σ = 0.643.
2. n = 2 × (1.96 + 0.842)² × 0.643² / -0.360² = 50.1, rounded up to 51 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -0.36                      # observed difference in means
sigma <- 0.643272881443016                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(925990)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 51 (80% power), 68 (90% power)
 75% of observed effect: n per arm = 90 (80% power), 120 (90% power)
 50% of observed effect: n per arm = 201 (80% power), 269 (90% power)
power.t.test: 51.1 
Simulated power at n = 51 per arm: 0.800 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when several outcomes, time points, treatment comparisons, or analyses are examined. In general, the more opportunities there are to find a nominally unusual result, the greater the chance that at least one will occur even if none reflects a real difference. Methods such as prespecifying a primary endpoint or adjusting statistical thresholds can address this issue, but the registry record does not report a multiplicity strategy. The primary p-value is explicitly unadjusted, and the secondary p-value is also presented as unadjusted.

The registry identifies one primary outcome and one secondary outcome, but this does not establish the complete set of outcomes assessed in the trial. It records two outcome measures, one posted secondary outcome, and zero reported analyses. The meaning and scope of that analysis count are not explained in the registry record. The record does not say whether additional time points, subgroups, or exploratory comparisons were examined, or whether the primary and secondary outcomes were specified before data were reviewed.

Missing data can affect both the estimated group means and the precision of comparisons. If participants with unobserved outcomes differ systematically from those with observed outcomes, an available-case estimate may not represent the randomized groups as a whole. The registry does not report how many participants had missing week-24 measurements, why any measurements were missing, or what method was used to handle missing data. It also does not describe sensitivity analyses for missingness.

The primary endpoint description states that all patients receiving at least one dose of study drug were analyzed for safety. That statement identifies a safety population, not necessarily the population used for the primary efficacy analysis. The efficacy analysis population, any exclusions after randomization, and whether participants were analyzed according to assigned group are not reported in the registry record. These distinctions matter because analysis-population choices can change the interpretation of a randomized comparison.

The registry records randomized allocation and quadruple masking, but it does not provide enough detail to assess the randomization process, concealment, masking roles, protocol deviations, or the full statistical analysis plan. These omissions do not invalidate the posted estimates, but they limit the ability to judge whether the analysis followed prespecified procedures and how robust the results are to alternative reasonable choices.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: colitis ulcerative (2.9%), lobar pneumonia (2.9%), spondylitic myelopathy (2.9%), chronic obstructive pulmonary disease (2.9%), staphylococcal abscess (2.9%).

For serious adverse events, the registry lists 3 affected participants among 35 at risk in the CTS-1027 plus ribavirin group and 6 among 35 at risk in the CTS-1027 plus placebo group. These are participant counts, not a complete description of the timing, duration, severity, or causal relationship of each event. The record lists serious event terms including colitis ulcerative, lobar pneumonia, spondylitic myelopathy, chronic obstructive pulmonary disease, staphylococcal abscess, and chest pain, each at 2.9%.

The listed terms describe events recorded as serious; they should not be interpreted as proof that a regimen caused an event. The registry does not provide event-level details or an investigator assessment of relatedness in the registry record for these results. It also does not report death counts, so deaths are not reported in the registry record.

The other adverse-event counts list 31 affected participants among 35 at risk in the ribavirin group and 29 among 35 at risk in the placebo-for-ribavirin group. These counts are distinct from serious adverse events and do not convey how many events each participant experienced. With the group sizes and event summaries alone, safety patterns are descriptive and do not establish comparative risk or provide a complete safety profile.

16. What the Result Does, and Does Not, Mean

The posted primary result describes a difference in average HCV-RNA change between two randomized groups over the baseline-to-24-week timeframe. The mean change was more negative in the CTS-1027 plus ribavirin group, and the estimated mean difference was -0.36 log (IU/mL). The unadjusted p-value is 0.019, and the posted confidence interval lies below zero. These figures indicate the direction and statistical uncertainty of the observed contrast under the analysis used.

That statistical pattern does not, by itself, establish clinical importance. The registry record does not state a threshold for a meaningful change in HCV-RNA, nor does it report whether the observed difference translated into outcomes beyond this laboratory measure and timeframe. The endpoint is not a direct measure of symptoms, quality of life, complications, or longer-term status. No treatment recommendation follows from these results alone.

The comparison is between CTS-1027 paired with ribavirin and CTS-1027 paired with placebo for ribavirin. It is not a direct comparison of CTS-1027 alone with no treatment, and the posted result cannot isolate the effect of CTS-1027 itself because both arms received it. The registry’s brief study summary describes an intent to assess CTS-1027 alone or in combination, while the posted arm descriptions identify the two combination regimens used for the reported comparison.

The secondary aminotransferase comparison is imprecise and does not show a clear between-group separation in the posted estimate. That does not prove the treatments have equal effects on that outcome. Both outcomes should be interpreted in light of the limited enrollment, the unadjusted analyses, and the missing details about the analysis population, missing measurements, and multiplicity.

The trial is listed as completed, but its posted results do not answer every question about efficacy or safety. The registry record does not report longer-term follow-up, a detailed protocol, subgroup results, or a full account of adverse events. The statistically appropriate conclusion is limited to describing the observed outcome summaries and their uncertainty, not asserting a definitive treatment effect or absence of effect.

17. Why This Trial Matters Statistically

This trial illustrates why a mean difference, a p-value, and a confidence interval answer related but distinct questions. The mean difference gives the direction and size of the observed contrast on the endpoint scale. The unadjusted p-value describes compatibility with a no-difference model under test assumptions. The confidence interval shows a range of values compatible with the data and conveys precision. None of these statistics alone states whether a difference matters clinically.

The primary and secondary outcomes also show why a trial should be interpreted across its outcome structure rather than by one statistic in isolation. The primary viral-load contrast has an interval lying below zero, while the aminotransferase contrast has an interval spanning both directions. Different measures need not produce identical patterns. Unadjusted secondary results carry less weight when multiplicity handling and prespecification are not reported.

The planning illustrations demonstrate how strongly sample-size requirements depend on the effect targeted. A smaller targeted effect requires more participants per arm for the same power under the stated assumptions. Because the calculations use the observed effect, they are planning examples rather than evidence that the original study was adequately powered or that the observed result has a particular probability of being true.

The registry information also makes analysis transparency important. Randomization and masking are recorded, but several details needed to fully evaluate the result are absent, including the efficacy analysis population, handling of missing data, the original sample-size justification, and the complete analysis plan. Separating what is reported from what remains unknown helps avoid overstating the inference from a small phase 2 comparison.

18. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The trial enrolled 70 participants, with 35 listed in each arm. This is a limited evidence base for characterizing variability, assessing uncommon outcomes, or estimating subgroup effects; subgroup results are not reported in the registry record. The primary comparison is an observed group-average contrast, and the registry does not provide participant-level distributions or baseline characteristics to assess balance and influential observations.

The primary outcome is restricted to change in HCV-RNA through 24 weeks. The registry does not report outcomes after that timeframe or describe whether the change was linked to later clinical outcomes. It also does not report a clinical-importance threshold for the log-scale difference. Interpretation is consequently limited to the stated laboratory measure and observation period.

Several analysis details are not reported in the registry record: the original sample-size justification, the efficacy analysis population, the handling of missing measurements, the complete prespecified statistical plan, and any adjustment for multiple testing. The safety population statement does not identify the primary efficacy population. The record does not state how many week-24 observations were missing or whether any randomized participants were excluded from the efficacy comparison.

The registry identifies the study as randomized and quadruple-masked but does not explain the allocation procedures or which parties were masked. The posted arm descriptions support a comparison of CTS-1027 plus ribavirin with CTS-1027 plus placebo; they do not provide a separate posted comparison of CTS-1027 alone with no treatment. These limitations constrain evaluation of conduct, generalizability, and the causal interpretation of the estimates.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: CTS-1027 in Interferon-Naive Hepatitis C Patients — NCT00925990.
• Registry record last updated 2012-03-27; status last verified 2012-02.
• Results first posted 2012-03-27.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

22. Record Summary

NCT00925990 is a completed randomized phase 2 parallel-group trial in interferon-naive patients with hepatitis C. The registry records quadruple masking and enrollment of 70. The posted arms are CTS-1027 plus ribavirin and CTS-1027 plus placebo, with 35 participants listed in each arm.

The primary outcome is mean change in HCV-RNA from baseline through 24 weeks. The estimated mean difference for CTS-1027 plus ribavirin compared with CTS-1027 plus placebo is -0.36 log (IU/mL), with an unadjusted p-value of 0.019. The registry also posts a secondary aminotransferase outcome, whose between-group estimate is imprecise.

The registry does not report the original sample-size justification, the efficacy analysis population, missing-data handling, multiplicity strategy, or full statistical analysis plan. The posted estimates describe this trial’s results and should be interpreted within those limits.