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 Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors (NCT03627299), a na phase 4 study. The primary outcome is Viral Response at Week 12.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03627299 |
| Phase | Phase 4 |
| Condition | End Stage Renal Disease, Hepatitis C |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 11 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Johns Hopkins University |
| Results posted | Yes |
2. Clinical Question
Population
People without hepatitis C infection who were on the kidney transplant waitlist and received a kidney from a deceased donor with hepatitis C infection. The registry record reports enrollment of 11 participants.
Intervention
Glecaprevir 300 mg and pibrentasvir 120 mg, administered around the transplant procedure and continued after transplantation. The study summary describes treatment beginning on-call to the operating room and continuing for 4 weeks post-transplant; the arm description specifies once-daily oral treatment for 4 weeks.
Comparator
There was no separate comparator group. The study is listed as a single-group trial with no masking, and allocation is listed as not applicable. It therefore does not make a randomized, like-for-like comparison between treatment strategies.
Primary question
Among the transplant recipients in the study, how many had undetectable hepatitis C RNA at 12 weeks after completing therapy? The registry defines the endpoint as the number of participants with HCV RNA below the lower limit of quantification at that time. The count and corresponding result are not reported in the registry record.
The question is about viral response after treatment in a specific transplant setting, rather than a comparison of outcomes between treatment and no treatment. The donor kidneys came from deceased donors described as HCV RNA PCR positive, while recipients were described as uninfected before transplantation. The intervention was intended to accompany transplantation and continue into the post-transplant period.
Other listed outcomes address viral response at earlier and later time points, antibody development, T-cell response, and kidney function. The record names these outcomes but does not report their results. Consequently, the central question can be described from the study plan, but the registry record does not establish how many participants met the primary endpoint or how uncertain that estimate is.
3. Trial Design
This is a phase 4, open-label, single-group pilot study sponsored by Johns Hopkins University. The registry lists 11 participants as enrolled, no masking, and allocation as not applicable. The study status is completed. Its recorded start date is 2018-09-25, and its primary completion date is 2019-12-19.
The study concerns people with end stage renal disease and hepatitis C as listed conditions. The clinical description focuses on recipients without hepatitis C infection who receive kidneys from deceased donors with hepatitis C infection. Participants in the named arm received glecaprevir 300 mg and pibrentasvir 120 mg once daily by mouth for 4 weeks. The brief description says treatment was administered on-call to the operating room for the transplant procedure and continued for 4 weeks post-transplant. The registry record does not provide further detail on treatment adherence or treatment changes.
A single-group design can describe outcomes among participants treated under the study conditions, but it does not provide a concurrent untreated or alternative-treatment group. Allocation is not applicable because no randomized allocation between arms is listed. With no masking, participants and study personnel were not blinded according to the design information in the registry record. The record does not report additional procedures intended to reduce assessment bias.
The primary outcome is viral response at week 12, defined as a participant count with undetectable hepatitis C RNA at 12 weeks after completing therapy. Listed secondary outcomes include viral response at 1, 2, 4, and 8 weeks, antibody development, T-cell response at baseline and 12 weeks, and kidney function at 6 months. The record also lists 11 outcome measures, but outcome results are not reported in the registry record.
The record does not report a sample-size justification, a detailed statistical analysis plan, or the analysis population definition. The planning assumptions associated with sample-size illustrations are not the trial’s own design rationale. No comparator-specific treatment effect can be estimated from this single-group design alone.
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.
Before assignment: Of 11 participants who signed consent, 10 received organ offers from HCV+ deceased donors. The remaining participant did not receive an offer before enrollment in the study closed.
Overall Study
| Stage | Deceased Donor HCV RNA PCR+ |
|---|---|
| STARTED | 10 |
| COMPLETED | 10 |
| NOT COMPLETED | 0 |
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 | Deceased Donor HCV RNA PCR+ |
|---|---|---|
| Participants analysed | 10 | |
| Age, Continuous | years | 67 (40 to 75) |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 7 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 |
| Race (NIH/OMB): White | Participants | 7 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Primary Cause of Renal Failure: Hypertension | Participants | 4 |
| Primary Cause of Renal Failure: Polycystic Kidney Disease | Participants | 2 |
| Primary Cause of Renal Failure: Glomerulonephritis | Participants | 2 |
| Primary Cause of Renal Failure: Nephrolithiasis | Participants | 1 |
| Primary Cause of Renal Failure: Reflux Nephropathy | Participants | 1 |
| Blood Type: O | Participants | 4 |
| Blood Type: A or AB | Participants | 5 |
| Blood Type: B | Participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Viral Response at Week 12, measured over 12 weeks after completing therapy.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the count of participants with undetectable hepatitis C RNA at 12 weeks after completing therapy. The registry describes this as HCV RNA below the lower limit of quantification at week 12. It is a binary status assessed for each participant—meeting or not meeting the stated viral-response definition—then expressed as a participant count.
Viral RNA measurement provides a direct way to classify whether the specified laboratory threshold has been met at the chosen follow-up time. The endpoint’s timing is after completion of therapy, so it concerns response at a defined point following treatment rather than an immediate measurement during the transplant procedure. The record does not give the assay details, the numerical lower limit of quantification, or rules for handling results that are missing or indeterminate.
General: a count is easy to interpret as the number of participants who met a prespecified condition. Its interpretation depends on knowing the number assessed as well as the number meeting the condition. A count alone does not describe the precision of an estimated response proportion, and it does not establish that treatment caused the observed outcomes. In a single-group study, the endpoint can describe outcomes in the enrolled group, but there is no concurrent comparator for estimating a treatment contrast.
The primary endpoint result itself, including the number of participants meeting the definition, is not reported in the registry record. Thus the endpoint’s definition is available, but its observed value and precision cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes an intervention and a primary outcome but does not report the primary outcome result. In particular, it gives no count of participants with HCV RNA below the lower limit of quantification at 12 weeks after completing therapy. Without that count, the posted results do not allow an assessment of the observed viral-response frequency or its precision. No conclusion about the primary endpoint can be drawn from its definition alone.
The record reports enrollment of 11 participants. This is the enrollment total, not necessarily the number assessed for every outcome. The number with an evaluable primary endpoint is not reported in the registry record. The record likewise does not give participant-level outcome information, a response proportion, or a confidence interval for the primary endpoint.
The study’s single-group design is important when interpreting any outcome. Outcomes among participants who received treatment can be described, but a comparison with an alternative strategy is not available from this design. Changes over time or outcomes observed after transplantation cannot, by themselves, separate the effect of treatment from other influences. The record does not report a randomized control group or a within-study comparator.
The design is also open-label. That describes the absence of masking; it does not show that assessment bias occurred. The registry record does not report specific safeguards for outcome assessment, nor does it provide enough detail to evaluate how the laboratory endpoint was ascertained. The stated endpoint is an RNA threshold, but assay procedures and handling of uncertain measurements are not reported.
Safety information is available in limited form. The adverse-event record lists 10 participants at risk for serious adverse events and 3 affected; for other adverse events, it lists 10 at risk and 0 affected. Deaths are listed as 0. Six serious-event terms are named, each with a reported value of 10.0%. These entries should be read as the registry’s reported safety figures, not as a comparison against another group. The registry record does not explain why the at-risk count is 10 while enrollment is 11, or provide further context on event timing, duration, or attribution.
The listed planning assumptions describe illustrations based on a fraction of an observed effect, equal allocation between two arms, a two-sided significance level of 0.05, and a normal approximation. Those assumptions do not describe the actual single-group study design. The registry record does not report the observed primary effect needed to interpret such illustrations in relation to this trial. Planning estimates are not observed power and should not be read as trial results.
Overall, the registry record permits description of the study question, design, endpoint definition, and selected adverse-event counts. It does not provide the primary efficacy result, a detailed statistical analysis plan, or outcome estimates with uncertainty. Interpretation should remain limited to these documented features.
9. Statistical Methods Explained
The study is listed as a single-group, open-label phase 4 trial. Its primary endpoint is a count: the number of participants meeting a laboratory definition of viral response at a specified follow-up time. The record does not list analyses for the outcome, and it does not report the primary outcome result. The discussion below explains relevant statistical ideas generally; it does not describe an analysis that the registry record says was performed.
What does a participant count describe?
For a binary endpoint, each participant is classified according to whether the defined event occurred. A count of participants meeting the definition is descriptive. To interpret it fully, readers also need to know the number of participants whose endpoint status was assessed. The registry record defines the primary outcome as a count and reports enrollment, but it does not report the number assessed for the primary endpoint or the count meeting it.
General: a response proportion is often used to put a count in the context of the assessed group. The denominator matters because an identical count can represent different proportions in groups of different sizes. A confidence interval can communicate the range of values reasonably compatible with the observed data under a statistical model. It reflects sampling uncertainty; it does not account for every possible source of bias or make a single-group study comparable to a randomized trial. No primary endpoint proportion or confidence interval is reported in the registry record.
What does the endpoint timing mean?
The endpoint is evaluated 12 weeks after completing therapy. This is a defined post-treatment time point, not a continuous measure of viral response over the entire follow-up period. The study also lists viral-response outcomes at 1, 2, 4, and 8 weeks, as well as antibody and T-cell outcomes and kidney function at 6 months. Those outcomes address different measurements or follow-up times and should not be treated as interchangeable with the primary endpoint. Their results are not reported in the registry record.
General: measurements at several time points can help describe the course of an outcome, but each time point raises questions about the analysis population, missing measurements, and the handling of multiple comparisons. The registry record does not say how repeated measurements were analyzed, whether any values were carried forward, or whether an overall longitudinal model was used.
What can a single-group design estimate?
A single-group study can report the outcomes observed in its participants. It cannot, by design alone, directly estimate the difference between the intervention and a concurrent comparator. The registry lists allocation as not applicable and no comparator arm. As a result, an outcome count cannot establish how the same participants would have fared under a different strategy.
General: randomization helps make groups comparable, on average, with respect to measured and unmeasured factors at the start of a study. A nonrandomized single group does not have that protection through a concurrent treatment comparison. Comparisons with external or historical data would require information about those data and methods for addressing differences; such comparisons are not reported in the registry record.
The open-label designation means masking is listed as none. General: knowledge of treatment assignment can influence participant-reported outcomes, clinical decisions, or outcome assessment in some settings. A laboratory-based endpoint may be less subjective than a judgment-based outcome, but its reliability still depends on measurement procedures and consistent assessment. Assay methods and any masking of laboratory personnel are not reported in the registry record.
How should planning illustrations be read?
The planning assumptions state a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. The assumptions also distinguish between participant counts per arm for most outcomes and total events for time-to-event outcomes. These are general planning inputs, not descriptions of the enrolled study: the trial is listed as single-group, with allocation not applicable.
A sample-size calculation asks how many observations a proposed design might require under chosen assumptions. Its result depends on the target effect, variability or event rate, error rate, design, and analysis method. If the target effect is based on an observed effect, that estimate may itself be uncertain. Planning illustrations are therefore conditional scenarios, not proof that a study has adequate power and not evidence that an outcome occurred. The registry record does not report its own sample-size justification, and the observed primary effect is not reported in the registry record. The planning assumptions should not be mistaken for an analysis plan or for observed power.
What is not described?
The registry record does not report a detailed statistical analysis plan, the analysis population, handling of missing measurements, or the method for calculating uncertainty around the primary count. It does not report whether any interim analyses were conducted. These omissions prevent readers from determining whether the analysis followed prespecified procedures or how participants with unavailable endpoint data were treated.
General: a prespecified analysis plan can clarify the outcome definition, population, handling of missing data, and inferential methods before results are examined. Such detail helps readers assess whether reported estimates answer the stated question and whether selective analytical choices could affect interpretation. The absence of this information in the registry record does not establish that no such procedures existed; it means they are not reported there.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Deceased Donor HCV RNA PCR+ | 10 | 10 | 100.0% | 69.2% to 100.0% | 72.2% to 100.0% | 71.5% to 99.8% |
R code and output
arm <- c("Deceased Donor HCV RNA PCR+")
n <- c(10)
events <- c(10)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM Deceased Donor HCV RNA PCR+ 10 10 100.0 69.2 100.0 72.2 100.0 71.5 99.811. Multiplicity, Missing Data and Analysis Populations
The registry lists several outcomes and several viral-response assessment times: 1, 2, 4, and 8 weeks, alongside the primary viral-response endpoint at 12 weeks after completing therapy. It also lists antibody development, T-cell response at baseline and 12 weeks, and kidney function at 6 months. When multiple outcomes or time points are examined, the chance of obtaining at least one apparently notable result can increase if each is tested separately. General: multiplicity methods can control or describe this issue, but the appropriate approach depends on the prespecified questions and analysis plan.
The registry record does not report whether a multiplicity adjustment was planned or used, how the primary endpoint was prioritized relative to secondary outcomes, or whether analyses were exploratory. It lists 11 outcome measures, but does not provide results for the listed outcomes. No inference about statistical significance across outcomes is possible from the record.
The analysis population is not reported in the registry record. Although enrollment is 11, the number assessed for the primary endpoint and the number included in each secondary analysis are not stated. Missing-data procedures, reasons for missing measurements, and rules for handling indeterminate laboratory results are also not reported. General: missing outcome data can affect both the denominator and the interpretation of an estimated response, particularly if missingness is related to participant status or outcome.
The record does not report interim analyses, stopping rules, or a detailed analysis plan. These details should not be inferred from the completed status or from the endpoint schedule. Without them, readers cannot assess whether all planned analyses were reported or how incomplete follow-up was handled.
12. 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 |
|---|---|---|---|
| Deceased Donor HCV RNA PCR+ | 3 | 10 | 30.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Deceased Donor HCV RNA PCR+ | 0 of 10 |
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 |
|---|---|
| Deceased Donor HCV RNA PCR+ | 0 of 10 |
Most frequent serious adverse event terms
| Event term | Organ system | Deceased Donor HCV RNA PCR+ |
|---|---|---|
| Renal Vein Thrombosis | Renal and urinary disorders | 1 of 10 |
| Acute Kidney Injury | Renal and urinary disorders | 1 of 10 |
| Hematuria | Renal and urinary disorders | 1 of 10 |
| Urosepsis | Infections and infestations | 1 of 10 |
| Perinephric Fluid Collection | Renal and urinary disorders | 1 of 10 |
| Urinary Tract Infection | Infections and infestations | 1 of 10 |
Serious events with the highest arm-level rate: renal vein thrombosis (10.0%), acute kidney injury (10.0%), hematuria (10.0%), urosepsis (10.0%), perinephric fluid collection (10.0%).
The registry safety record lists 10 participants at risk for serious adverse events and 3 participants affected. For other adverse events, it lists 10 participants at risk and 0 affected. Deaths are listed as 0. The record does not explain why the at-risk count is 10 when total enrollment is 11, so these safety denominators should not be assumed to include every enrolled participant.
The serious-event terms listed are renal vein thrombosis, acute kidney injury, hematuria, urosepsis, perinephric fluid collection, and urinary tract infection. Each term has a reported value of 10.0%. The registry record does not provide additional detail about event timing, severity grades, duration, recurrence, or whether an event was considered related to treatment or transplantation. The term-level percentages should therefore be read as reported, without inferring additional event counts or clinical context.
General: safety summaries distinguish participants who experienced an event from the total at risk, and a participant may potentially experience more than one event. Event counts and participant counts are not always equivalent. These figures do not establish whether an event was caused by the study intervention, and a single-group study cannot compare event frequencies against a concurrent control group. The registry record does not report a comparative safety analysis.
The listed counts describe the registry’s safety entries; they are not a complete account of all possible safety outcomes. No further safety findings should be inferred from the listed serious-event terms or from the zero reported for other adverse events.
13. What the Result Does, and Does Not, Mean
The record establishes that an open-label, single-group pilot study enrolled 11 participants to examine glecaprevir and pibrentasvir treatment in hepatitis C-uninfected kidney transplant recipients receiving kidneys from deceased donors with hepatitis C infection. It defines a primary viral-response endpoint at 12 weeks after completing therapy and lists additional virologic, immunologic, and kidney-function outcomes.
However, the primary endpoint result is not reported in the registry record. The record does not give the number of participants who met the viral-response definition, the number assessed, or a measure of uncertainty. Consequently, it is not possible to judge the observed frequency or precision of the primary outcome from this record. The listed outcome definitions do not substitute for outcome results.
The single-group design also limits what outcomes could establish, even if complete results were available. Without a concurrent comparator, observed outcomes cannot estimate a randomized difference between treatment strategies. The open-label design describes the masking status but does not by itself determine whether assessments were biased. Detailed methods for endpoint assessment and analysis are not reported.
The safety entries provide selected counts: 3 participants affected among 10 at risk for serious adverse events, 0 affected among 10 at risk for other adverse events, and 0 deaths. Six serious-event terms are listed, each with a reported value of 10.0%. These entries do not establish causation or permit comparison with another treatment group. The reason the safety denominator differs from enrollment is not reported in the registry record.
General: a pilot study can contribute descriptive evidence about a defined setting and can inform questions for further research, but its interpretation depends on the observed results, completeness of follow-up, and study methods. The record does not provide the primary result or enough methodological detail to assess these matters fully. The findings should therefore be understood as unavailable in this registry entry, not as evidence for or against a treatment effect.
14. Why This Trial Matters Statistically
This trial raises a statistical question in a setting where the recipient and donor are described differently with respect to hepatitis C: recipients were uninfected, while donor kidneys were from deceased donors with hepatitis C infection. The study’s primary endpoint focuses on a laboratory-defined viral response after treatment. Clear endpoint definitions and follow-up timing matter because they determine exactly what an outcome count represents.
Statistically, the single-group design makes descriptive estimation central. The study can describe outcomes among enrolled participants if those outcomes are reported, but it does not provide a concurrent randomized comparison. This distinction prevents a descriptive response count from being interpreted as a treatment contrast. The registry record’s lack of a primary outcome result means even the descriptive endpoint cannot be evaluated from the posted record.
The trial also illustrates why denominators and analysis populations matter. Enrollment is 11, while the safety record lists 10 participants at risk. The record does not explain that difference, and it does not state how many participants had evaluable primary outcome data. Readers need the relevant denominator to interpret a count or percentage, as well as information about missingness and follow-up.
Multiple outcomes and assessment times create further interpretive questions. Viral response is listed at several time points, alongside antibody development, T-cell response, and kidney function. Without a reported analysis plan or results, it is not possible to determine how these outcomes were prioritized or whether multiplicity was addressed.
The statistical importance of the trial record is therefore not a claim about outcome success or failure. It lies in the need to distinguish an endpoint definition from an observed estimate, a single-group description from a controlled effect, and planning assumptions from the study actually conducted. The record supplies a study framework and selected safety counts, while leaving the primary result and key analysis details unreported.
15. 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 primary limitation for interpreting this trial is that the registry record does not report the primary viral-response result. It also does not state how many participants had an evaluable measurement at the endpoint or provide an uncertainty estimate. Without those details, the central outcome cannot be quantitatively assessed.
The enrolled group is reported as 11 participants, and the design is single-group. There is no concurrent comparator, so the study design does not support a direct randomized comparison of treatment strategies. The record also lists no masking. These design features should be considered when interpreting any reported outcomes, but the registry record does not provide enough outcome information to assess their impact in this study.
The safety denominator is reported as 10 participants at risk, rather than the enrollment total of 11. The reason for this difference is not reported in the registry record. The record does not explain participant flow, exclusions, withdrawals, or outcome-specific analysis populations. It also does not report the handling of missing or indeterminate viral measurements.
Other limitations of the available record include the absence of a detailed statistical analysis plan, sample-size justification, and information about interim analyses. Assay details, laboratory assessment procedures, treatment adherence, and event attribution are not reported. Listed secondary outcomes do not have reported results in the registry record.
The primary endpoint is measured at 12 weeks after completing therapy, while kidney function is listed at 6 months. The record does not provide longer-term results or explain whether additional follow-up occurred. These limits concern the information available in the registry record; they do not establish what procedures may or may not have been conducted outside the record.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors — NCT03627299.
- Registry record last updated 2021-10-19; status last verified 2021-09.
- Results first posted 2020-08-24.
- 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.
19. Record Summary
NCT03627299 is a completed phase 4, open-label, single-group pilot study sponsored by Johns Hopkins University. It enrolled 11 participants and examined glecaprevir 300 mg with pibrentasvir 120 mg in uninfected kidney transplant recipients receiving kidneys from deceased donors with hepatitis C infection. The registry lists a start date of 2018-09-25 and a primary completion date of 2019-12-19.
The primary endpoint is the count of participants with HCV RNA below the lower limit of quantification at 12 weeks after completing therapy. The registry record does not report the primary endpoint result or the number assessed. It lists secondary outcomes involving viral response at other time points, antibody development, T-cell response, and kidney function, without reporting their results.
Safety entries list 3 participants affected among 10 at risk for serious adverse events, 0 among 10 at risk for other adverse events, and 0 deaths. Six serious-event terms are listed, each with a reported value of 10.0%. The record does not report a comparator group, detailed statistical analysis plan, analysis populations, or missing-data procedures.