This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Assess the Antifibrotic Activity of Fuzheng Huayu in Chronic Hepatitis C Patients With Hepatic Fibrosis (NCT00854087), a randomized phase 2 study. The primary outcome is Safety of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00854087 |
| Phase | Phase 2 |
| Condition | Chronic Hepatitis C Infection |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 118 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Tarek Hassanein |
| Results posted | Yes |
2. Clinical Question
Population
People with chronic hepatitis C and hepatic fibrosis who had failed prior anti-HCV therapy or could not receive or had refused interferon-based therapy. The primary outcome population is described as participants randomized and receiving at least one dose of study treatment.
Intervention
Fuzheng Huayu, described as a pill containing Fuzheng Huayu.
Comparator
Placebo, described as a pill without Fuzheng Huayu.
Primary question
What safety findings were recorded during the period from baseline to Week 60 for participants receiving Fuzheng Huayu or placebo? The registry describes safety assessment through vital signs, physical examinations, adverse events, concomitant medication assessments, and laboratory tests.
The central question is about safety in a specific clinical context, not whether Fuzheng Huayu clears hepatitis C or changes fibrosis. The trial title identifies chronic hepatitis C patients with hepatic fibrosis, while the primary outcome title further characterizes the population by prior treatment failure or inability or unwillingness to receive interferon-based therapy. The registry record does not report a primary efficacy comparison or a measured change in fibrosis as the primary outcome.
The posted safety figures include participants with serious adverse events and counts for other adverse events. These counts describe what was recorded in each group; they do not, by themselves, establish why an event occurred or whether the groups differ beyond the observed counts. The record does not list a statistical analysis comparing the groups. Interpretation therefore needs to stay close to the recorded safety outcome and its stated assessment period.
3. Trial Design
This was a phase II, randomized, placebo-controlled, double-blind, multicenter study with a parallel-group design. The registry lists Fuzheng Huayu and placebo as the interventions. The Fuzheng Huayu arm received a pill with Fuzheng Huayu, and the placebo arm received a pill without Fuzheng Huayu. The listed enrollment is 118.
Random allocation is intended to assign participants to the study groups by chance rather than by clinical choice. In general, this can help balance participant characteristics across groups, although chance imbalances can remain, particularly in a trial of this size. The registry record does not describe the allocation sequence, how allocation was concealed, or whether any stratification was used.
Double masking means that the registry identifies the trial as masked for both participants and investigators, but it does not specify which other trial personnel, if any, were masked. A placebo comparator can support a masked comparison when the study treatments are distinguishable only to those who need to know assignment; the record does not provide details about how masking was maintained or assessed.
The registry lists the study start as 2010-08 and primary completion as 2013-04, and its status is completed. The primary outcome timeframe is baseline to Week 60. The record does not state how many participants completed follow-up, whether follow-up differed by group, or how long-term outcomes beyond the stated primary timeframe were handled. Nor does it report the centers’ locations or the criteria used to select participating centers.
These design features describe how the comparison was set up, but they do not establish what analysis was planned or how missing outcome information was treated. Statistical analysis details and the protocol’s sample-size justification are not reported in the registry record. Consequently, the posted group counts can be described, but the design description alone is not enough to determine the precision of a formal treatment comparison.
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
| Stage | Fuzheng Huayu | Placebo |
|---|---|---|
| STARTED | 59 | 59 |
| COMPLETED | 40 | 40 |
| NOT COMPLETED | 19 | 19 |
Analysis population for the primary outcome, as defined in the registry: Number of participants randomized and who received at least one dose of Fuzheng Huayu or Placebo.
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.
| Characteristic | Unit | Fuzheng Huayu | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 59 | 59 | 118 | |
| Age, Continuous | years | 55.4 (SD 6.72) | 55.1 (SD 8.61) | 55.3 (SD 7.67) |
| Sex: Female, Male: Female | Participants | 25 | 23 | 48 |
| Sex: Female, Male: Male | Participants | 34 | 36 | 70 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 5 | 9 | 14 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 54 | 50 | 104 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| HCV Genotypes: 1 | participants | 48 | 52 | 100 |
| HCV Genotypes: 2 | participants | 4 | 1 | 5 |
| HCV Genotypes: 3 | participants | 6 | 5 | 11 |
| HCV Genotypes: 4 | participants | 1 | 0 | 1 |
| HCV Genotypes: Other | participants | 0 | 1 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Safety of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy., measured over Baseline to Week 60.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is titled as the safety of Fuzheng Huayu treatment in chronic hepatitis C subjects who failed prior anti-HCV therapy or could not receive or refused interferon-based therapy. It is measured in participants, with the population defined as those randomized who received at least one dose of Fuzheng Huayu or placebo. The stated timeframe is baseline to Week 60.
Safety is described as being evaluated through changes in vital signs, physical examinations, adverse events, concomitant medication assessments, and laboratory tests. This is a broad clinical monitoring outcome rather than a single laboratory value or a single disease-progression measure. The record does not specify thresholds for clinically important changes, a composite definition of safety, or how findings across these different assessments were combined.
Safety outcomes are used to characterize potential unwanted effects and other health findings observed during treatment and follow-up. In general, such assessments can help describe the kinds and frequency of events recorded in each group. They do not alone determine whether an event was caused by the assigned treatment, and counts can be difficult to compare without clear definitions, follow-up completeness, and an analysis plan. The posted serious and other adverse-event counts offer part of the safety picture, but the registry does not report results for every listed safety assessment.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports serious adverse events for the Fuzheng Huayu group as 7 participants among 59 at risk and for the placebo group as 10 participants among 59 at risk. It reports other adverse-event counts of 55 among 59 at risk in each group. These are descriptive counts. The record does not list a statistical analysis for these outcomes, so the counts should not be presented as a formal test of a difference between groups.
The figures also do not establish whether an event was caused by study treatment. The registry record does not provide event-level narratives, attribution judgments, timing, duration, severity grades beyond the serious-event classification, or details about recurrence. Nor does it explain whether participants could contribute more than one event to the event listings. Participant counts and event counts are not interchangeable; the posted summaries are described in participants, while the detailed counting rules are not reported.
The serious-event terms with the largest listed percentages are pneumonia and cholecystitis, each at 3.4%. Sinus infection, hypotension, bowel obstruction, and abdominal pain are each listed at 1.7%. The record does not clarify whether these percentages refer to participants or events, whether categories overlap, or what denominator was used for each term. They should therefore be read as the percentages accompanying the registry’s term listings, not as independently established rates.
Deaths are not reported in the registry record. That absence should not be interpreted as evidence that no deaths occurred. The registry also does not provide results for the vital-sign, examination, concomitant-medication, and laboratory components named in the primary outcome description. The adverse-event summaries consequently represent only the information actually posted, not a complete account of every safety assessment.
The trial is randomized and double-blind according to the record, but these design features do not resolve uncertainty about the result summaries. The record does not report confidence intervals, hypothesis tests, adjustment for baseline characteristics, or an analysis population beyond the primary outcome’s description. The observed counts can be stated as recorded, but the precision and statistical compatibility of possible group differences cannot be quantified from the registry information.
Overall, the registry provides a descriptive account of serious and other adverse-event counts across the study groups. The counts do not establish a causal explanation or a statistically supported difference. They also do not answer an efficacy question about fibrosis or viral clearance, because the listed primary outcome concerns safety.
9. Statistical Methods Explained
The statistical information in the registry is limited. It identifies a randomized parallel-group design and describes a participant-count safety outcome, but it does not list a statistical analysis for the primary outcome. In general, a methods description should connect the outcome definition, analysis population, comparison, uncertainty measure, and missing-data handling. Those details are not reported in the registry record, so they cannot be reconstructed from the posted counts.
What does a participant count represent?
The primary outcome is expressed as a count of participants. For an adverse-event outcome, this usually means counting participants who meet a stated event definition during a specified observation period. Here, the record gives the primary timeframe as baseline to Week 60 and describes a population of participants randomized and receiving at least one dose. The record does not give a full operational definition for each safety component or explain whether a participant with repeated events is counted once or multiple times in each posted summary.
In general, counts are most interpretable when the event definition, group denominator, observation period, and counting unit are all clear. The serious and other adverse-event summaries include 59 participants at risk in each group. That makes the listed counts understandable as group summaries, but it does not supply every detail needed to calculate or interpret an inferential comparison. No new rates or effect estimates are calculated in this explanation.
Why distinguish description from inference?
A descriptive result reports what was observed in the study groups. An inferential analysis uses a specified statistical model or test to quantify uncertainty about a comparison, often through a confidence interval or a hypothesis test. In general, a confidence interval describes a range of values compatible with the data and assumptions of the analysis; it is not a guarantee that the true value lies in that range. A hypothesis test addresses a prespecified statistical question under its assumptions, but a test result does not establish causation on its own.
The registry does not list such an analysis for the primary outcome. There are no posted confidence intervals or test results for the serious adverse-event counts. The counts should therefore remain descriptive rather than being treated as evidence that the groups are statistically equivalent or different. A lack of a reported test is not evidence that a formal analysis found no difference.
What can randomization and masking contribute?
In general, random allocation can reduce systematic differences in prognostic characteristics between treatment groups, and masking can reduce the influence of expectations on care or outcome assessment. These protections depend on how the allocation and masking procedures are implemented. The record identifies the trial as randomized and double-blind but does not explain sequence generation, concealment, or the success of masking. It is therefore possible to describe the design labels, but not to assess implementation from the registry description alone.
How should planning illustrations be understood?
The registry’s sample-size assumptions describe planning illustrations computed from an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. These are planning assumptions, not a report of the trial’s original design rationale. The registry does not report the trial’s own sample-size justification.
In general, sample-size calculations estimate how many participants might be needed for a future study under chosen assumptions. They are not observed power and do not show that the current trial was adequately powered for its outcomes. The record also states that the primary outcome has several categories or time points and is not reduced to one comparison. No specific planning result for this primary outcome is stated in the registry record, so no sample-size figure can be used to support a conclusion about the precision of the posted safety findings.
Why do definitions and dispersion matter?
General statistical methods must match the outcome. A binary participant outcome, such as whether a participant experienced a defined event, can be analyzed using methods for proportions. Repeated events, counts of events, or measurements taken at multiple times may require different approaches. For count data, over-dispersion means that variability exceeds what a simple count model assumes; ignoring it can make uncertainty appear too small. The registry record does not report a model, dispersion assumption, or method for repeated or multiple events, so none should be attributed to this trial.
The primary description also spans multiple safety domains, including examinations, laboratory tests, medications, and adverse events. In general, combining many outcomes raises questions about which comparisons were prespecified and how to interpret chance findings across them. The registry record does not report a statistical analysis plan, a hierarchy of outcomes, or a method for handling multiple comparisons. These omissions limit what can be inferred from the outcome summaries, even though the study design itself is described.
10. Multiplicity, Missing Data and Analysis Populations
The primary safety description includes several assessment domains: vital signs, physical examinations, adverse events, concomitant medication assessments, and laboratory tests. The registry does not explain whether these were treated as separate outcomes, combined into a summary, or organized in a prespecified hierarchy. It also does not report which safety findings were designated for formal comparison.
In general, multiplicity arises when several outcomes, time points, subgroups, or statistical tests are examined. The more comparisons made, the more opportunities there may be for chance findings. Researchers can address this through prespecified priorities or statistical adjustment, but the appropriate approach depends on the study question and analysis plan. The registry record does not report a multiplicity strategy, so it is not possible to determine how multiple safety assessments were handled.
The registry indicates that the primary outcome has several categories or time points and is not reduced to one comparison. No listed analyses are reported. This means that a single inferential result for the primary outcome cannot be identified from the posted record. It does not establish whether analyses were conducted outside the registry.
Missing-data procedures are also not reported. The record does not state how participants with incomplete follow-up, missing laboratory results, or incomplete adverse-event information were handled. It does not report whether analyses used an intention-to-treat population, a per-protocol population, or another analysis set. The primary outcome population is described as randomized participants who received at least one dose, but that description does not answer how missing observations were treated or whether all such participants contributed to every assessment.
These gaps matter because incomplete follow-up and multiple outcome assessments can affect the interpretation of safety summaries. Without the analysis population, missing-data approach, and multiplicity plan, the registry supports a descriptive reading of the posted counts, not a reconstruction of the trial’s full statistical analysis.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Fuzheng Huayu | 7 | 59 | 11.9% |
| Placebo | 10 | 59 | 16.9% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Fuzheng Huayu | 55 of 59 |
| Placebo | 55 of 59 |
Most frequent serious adverse event terms
| Event term | Organ system | Fuzheng Huayu | Placebo |
|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | 0 of 59 | 2 of 59 |
| Bowel Obstruction | Gastrointestinal disorders | 1 of 59 | 1 of 59 |
| Abdominal Pain | Gastrointestinal disorders | 1 of 59 | 1 of 59 |
| Cholecystitis | Hepatobiliary disorders | 2 of 59 | 0 of 59 |
| Sinus Infection | Respiratory, thoracic and mediastinal disorders | 0 of 59 | 1 of 59 |
| Hypotension | Vascular disorders | 0 of 59 | 1 of 59 |
| Alcohol Rehabilitation | Social circumstances | 0 of 59 | 1 of 59 |
| Atypical Chest Pain | General disorders | 1 of 59 | 0 of 59 |
| T-12 Compression | Injury, poisoning and procedural complications | 0 of 59 | 1 of 59 |
| Opiod Overdose | Injury, poisoning and procedural complications | 1 of 59 | 0 of 59 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Fuzheng Huayu | Placebo |
|---|---|---|---|
| Gastrointestinal disorders such as nausea | Gastrointestinal disorders | 39 of 59 | 30 of 59 |
| General disorders such as fatigue | General disorders | 27 of 59 | 21 of 59 |
| Infections such as urinary tract infection | Infections and infestations | 24 of 59 | 20 of 59 |
| Respiratory such as cough | Respiratory, thoracic and mediastinal disorders | 20 of 59 | 24 of 59 |
| Nervous system disorders such as headache | Nervous system disorders | 20 of 59 | 21 of 59 |
| Psychiatric disorders such as depression | Psychiatric disorders | 15 of 59 | 15 of 59 |
| Skin and subcutaneous system disorders such as rash | Skin and subcutaneous tissue disorders | 14 of 59 | 13 of 59 |
| Injury, posioning and procedural complications such as muscle strain | Injury, poisoning and procedural complications | 10 of 59 | 12 of 59 |
| Investigations such as liver biopsy | Investigations | 6 of 59 | 8 of 59 |
| Surgical and medical procedures such as knee surgery | Surgical and medical procedures | 6 of 59 | 8 of 59 |
Serious events with the highest arm-level rate: pneumonia (3.4%), cholecystitis (3.4%), sinus infection (1.7%), hypotension (1.7%), bowel obstruction (1.7%).
The registry reports serious adverse-event counts for Fuzheng Huayu as 7 participants among 59 at risk and for placebo as 10 among 59 at risk. Other adverse-event counts are 55 among 59 at risk in each group. These are participant counts, as indicated by the registry’s outcome format. They should not be read as event totals unless the registry says that multiple events per participant were counted, which it does not explain.
The listed serious-event terms and their accompanying percentages are pneumonia at 3.4%, cholecystitis at 3.4%, sinus infection at 1.7%, hypotension at 1.7%, bowel obstruction at 1.7%, and abdominal pain at 1.7%. The registry does not explain the denominator or whether one participant could appear under more than one term. The percentages therefore retain the meaning and limitations of the registry listing rather than serving as independently interpretable incidence estimates.
Deaths are not reported in the registry record. No causal attribution, confidence interval, or statistical comparison is posted for these safety figures. In general, adverse-event summaries describe observations and do not alone establish that treatment caused an event or that a difference between groups is meaningful.
12. What the Result Does, and Does Not, Mean
The registry record describes a phase II randomized, double-blind comparison of Fuzheng Huayu with placebo in people with chronic hepatitis C and hepatic fibrosis. Its primary outcome concerns safety over baseline to Week 60. The posted results report serious and other adverse-event counts, but do not provide a statistical comparison or uncertainty estimates for those counts.
Those summaries can be used to describe the observed safety information in the record. They cannot, on their own, show that the treatment caused or prevented an event. Nor can they establish that the groups are the same: a descriptive difference or similarity in counts is not equivalent to a formal analysis of uncertainty. The record does not report confidence intervals, hypothesis tests, or an analysis plan that would support a more detailed comparison.
The primary outcome description names several types of safety assessment, but results for all of those components are not reported in the posted information. The serious-event term percentages also lack a stated denominator and counting explanation. These limitations mean that the posted event summaries do not constitute a complete account of all safety observations or a full interpretation of the endpoint.
The record does not report a primary efficacy result for fibrosis or viral clearance. The trial’s title and background discuss hepatic fibrosis and chronic hepatitis C, but those subjects should not be confused with the stated primary safety outcome. No conclusion about efficacy, disease progression, or clinical benefit follows from the safety counts alone.
In practical statistical terms, the record supports a narrow conclusion: it documents specified participant counts and serious-event terms for the study groups, while leaving the inferential analysis and several outcome details unreported. Further interpretation would require information that is not reported in the registry record, including the full analysis plan, event definitions, missing-data handling, and results for the other safety assessments.
13. Why This Trial Matters Statistically
This trial is statistically relevant because it shows why a registry entry’s design description and its reported results need to be read together. Randomization, masking, a placebo comparator, and a parallel-group structure describe an approach intended to support a controlled comparison. But those features do not substitute for a reported outcome definition, analysis plan, uncertainty estimate, or explanation of missing observations.
The primary outcome is broad, covering vital signs, physical examinations, adverse events, concomitant medication assessments, and laboratory tests. Broad safety monitoring can be clinically useful, but statistically it raises questions about how many outcomes were examined, which findings were prioritized, and how results were summarized. The registry record does not report those decisions or a method for addressing multiplicity.
The posted safety counts also illustrate the distinction between event summaries and treatment-effect estimates. Counts can communicate what was recorded in each group, while formal inference requires explicit methods and measures of uncertainty. Without those methods, readers should not interpret a difference in counts as a definitive comparison or treat similar counts as proof of equivalence.
Finally, a sample-size planning illustration based on an observed effect is not a substitute for the trial’s own design justification or an analysis of its achieved precision. The registry record does not report the original sample-size rationale, and its primary outcome is not reduced to one comparison. This matters when judging what the study can say: the observed safety summaries are informative as descriptive reporting, but their statistical interpretation remains limited by the analysis details not reported.
14. 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 registry record gives limited detail about the primary safety outcome. It lists several assessment domains but does not define thresholds for changes, explain how the domains were combined, or specify which safety findings were formally compared. This makes it difficult to identify a single estimand, meaning the precise treatment-related quantity the analysis was intended to estimate.
The event summaries do not include a detailed account of event definitions, timing, duration, severity grading beyond the serious classification, or attribution to study treatment. The registry also does not explain whether percentages for serious-event terms use participants or events as the denominator, or whether categories can overlap. Deaths are not reported in the registry record, and the absence of a reported value does not establish that none occurred.
The record does not report the analysis plan, confidence intervals, hypothesis tests, missing-data procedures, or a full description of analysis populations. It also does not describe how the planned double masking and randomization were implemented. These omissions prevent assessment of the precision of the reported counts, the impact of incomplete follow-up, and the extent to which the stated design protections were maintained.
The registry reports enrollment of 118 and lists 59 participants at risk in each group for the adverse-event summaries, but it does not report follow-up completion or results for every safety assessment named in the primary outcome. The primary outcome also has several categories or time points and is not reduced to one comparison. These limitations constrain interpretation to the descriptive information actually posted.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Assess the Antifibrotic Activity of Fuzheng Huayu in Chronic Hepatitis C Patients With Hepatic Fibrosis — NCT00854087.
- Registry record last updated 2021-05-19; status last verified 2021-04.
- Results first posted 2014-06-18.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT00854087 is a completed phase II, randomized, double-blind, placebo-controlled, multicenter parallel-group study titled “Assess the Antifibrotic Activity of Fuzheng Huayu in Chronic Hepatitis C Patients With Hepatic Fibrosis.” The registry lists enrollment of 118, a study start of 2010-08, and primary completion in 2013-04.
The primary outcome concerns safety from baseline to Week 60 in participants randomized and receiving at least one dose. Safety assessments are described as including vital signs, physical examinations, adverse events, concomitant medication assessments, and laboratory tests. The posted serious adverse-event counts are 7 among 59 at risk for Fuzheng Huayu and 10 among 59 at risk for placebo; other adverse-event counts are 55 among 59 in each group.
The registry record does not report a statistical analysis for the primary outcome, missing-data methods, or results for every named safety assessment. The posted counts therefore support descriptive interpretation, while a formal comparative conclusion is not reported in the registry record.