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 Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL) (NCT02251041), a randomized phase 2 study. The primary outcome is Peak Aspartate Aminotransferase Within First 72h Post Transplant.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02251041 |
| Phase | Phase 2 |
| Condition | Reperfusion Injury |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 143 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
| Results posted | Yes |
2. Clinical Question
Population
Eligible recipients undergoing liver transplantation were the target population. The registry record lists reperfusion injury as the condition and reports enrollment of 143, but does not provide further eligibility criteria or a detailed description of the analyzed population.
Intervention
The intervention was a combined drug approach administered in connection with liver transplantation. The registry lists antithrombin-III, infliximab, apotransferrin, human recombinant erythropoietin, C1-inhibitor, glutathione, alfa-tocopherol, and melatonin among the interventions. The brief summary also names epoprostenol as part of the intended combination.
Comparator
The control group received placebo, described as sodium chloride solution, rather than the drug combination. The registry labels the control arm “Controles.” It does not report further details about placebo administration or the timing of each intervention.
Primary question
The primary outcome was peak serum aspartate aminotransferase (AST), measured within 72 hours following liver transplantation. The question is whether the posted peak AST results differ between recipients assigned to the combined drug approach and those assigned to placebo. The registry record provides a geometric mean and 95% confidence interval for each arm, but does not report a between-arm estimate or a statistical test for this primary outcome.
3. Trial Design
CAPITL is identified in the registry as a phase 2, randomized, single-masked, parallel study. It compared a combined drug approach with a placebo group during liver transplantation. The record describes the study as a first-in-men study and lists reperfusion injury as its condition. The study is marked completed.
The registry reports enrollment of 143. For the primary AST outcome, it posts 36 participants in the combined drug arm and 36 in the control arm. It does not explain the relationship between the enrollment figure and the arm-level numbers for that outcome, nor does it say whether the outcome numbers reflect a particular analysis population or exclusions.
The study began in 2014-09, with primary completion in 2019-02. Its parallel design means the intervention and placebo groups are distinct trial arms rather than repeated treatment periods within the same participant. Random allocation is reported, but the method used to generate or conceal the allocation sequence is not reported in the registry record. Single masking is reported, but the record does not identify who was masked.
The intervention is described as a combination rather than as a test of each named drug separately. Thus, the arm-level comparison addresses the combined approach against placebo; it does not isolate the contribution of any individual component. The record lists secondary outcomes including graft loss, recipient death, early graft dysfunction, biliary strictures, ischemia-reperfusion injury score, graft rejection, and severe surgical complications. It does not report a detailed protocol or statistical analysis plan.
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 143 enrolled participants, 93 were randomized. Reasons for exclusion of enrolled participants was : * Patients deceased before transplantation (on waiting list) * Patients not eligible anymore for transplantation * Included in other clinical trials * Change from single liver transplantation to combined transplantation (liver-kidney)
Overall Study
| Stage | Combined Drug Approach | Controles |
|---|---|---|
| STARTED | 53 | 40 |
| COMPLETED | 38 | 36 |
| NOT COMPLETED | 15 | 4 |
Reasons for not completing this period:
| Reason | Combined Drug Approach | Controles |
|---|---|---|
| Did not receive intervention | 15 | 4 |
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 | Combined Drug Approach | Controls | Total |
|---|---|---|---|---|
| Participants analysed | 38 | 36 | 74 | |
| Age, Continuous | years | 59 (53 to 66) | 60 (51 to 68) | 60 (51 to 66) |
| Sex: Female, Male: Female | Participants | 10 | 11 | 21 |
| Sex: Female, Male: Male | Participants | 28 | 25 | 53 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | — | — | 0 |
| Race (NIH/OMB): Asian | Participants | — | — | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | — | — | 0 |
| Race (NIH/OMB): Black or African American | Participants | — | — | 0 |
| Race (NIH/OMB): White | Participants | — | — | 0 |
| Race (NIH/OMB): More than one race | Participants | — | — | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | — | — | 0 |
| Donor age | years | 57 (49 to 70) | 59 (48 to 68) | 59 (48 to 69) |
| Donor type: Donation after Brain Death | Participants | 26 | 23 | 49 |
| Donor type: Donation after Circulatory Death | Participants | 12 | 13 | 25 |
| Warm ischemia time if Donation after Circulatory Death | minutes | 17 (16 to 21) | 16 (12 to 25) | 17 (13 to 21) |
| Intensive Care Unit Length of stay (donor) | days | 3 (1 to 7) | 4 (3 to 7) | 4 (2 to 7) |
| Donor cause of death: Trauma | Participants | 6 | 11 | 17 |
| Donor cause of death: Cerebrovascular accident | Participants | 20 | 11 | 31 |
| Donor cause of death: Anoxia | Participants | 0 | 2 | 2 |
| Donor cause of death: Other | Participants | 12 | 12 | 24 |
| Type of preservation solution: HTK (Histidine-tryptophan-ketoglutarate) | Participants | 6 | 5 | 11 |
| Type of preservation solution: UW (University of Wisconsin) | Participants | 7 | 5 | 12 |
| Type of preservation solution: IGL-1 (Institut Georges Lopez-1) | Participants | 25 | 25 | 50 |
| Type of preservation solution: Other | Participants | 0 | 1 | 1 |
| Brain death duration | hours | 13.3 (10.5 to 17.1) | 14.3 (10.0 to 20.8) | 13.5 (10.4 to 19.6) |
| Donor hepatectomy duration | minutes | 34.5 (25.0 to 46.0) | 32.5 (26.0 to 42.5) | 34 (25.5 to 43.8) |
| Cold ischemia time | hours | 5.8 (4.8 to 8.1) | 5.8 (5.1 to 8.1) | 5.8 (5.0 to 8.0) |
| Model for End-Stage Liver Disease score (MELD) | score on a scale | 13.2 (8.7 to 19.1) | 13.8 (10.8 to 19.4) | 13.6 (10.2 to 19.2) |
| Indication for liver transplant: Metabolic disease | participants | 4 | 3 | 7 |
| Indication for liver transplant: HCC | participants | 18 | 12 | 30 |
| Indication for liver transplant: Chronic liver disease | participants | 25 | 18 | 43 |
| Indication for liver transplant: Ethyl | participants | 23 | 18 | 41 |
| Indication for liver transplant: HBV | participants | 2 | 0 | 2 |
| Indication for liver transplant: HCV | participants | 2 | 0 | 2 |
| Indication for liver transplant: Cholestatic disease | participants | 4 | 4 | 8 |
| Indication for liver transplant: Nonalcoholic Steatohepatitis | participants | 2 | 10 | 12 |
| Indication for liver transplant: Cryptogenic | participants | 1 | 0 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Peak Aspartate Aminotransferase Within First 72h Post Transplant, measured over within 72 hours following liver transplantation.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | U/L |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the highest serum AST value recorded within 72 hours following liver transplantation. AST is an enzyme measured in blood; in general, changes in its level can serve as a biochemical indicator of tissue injury. The endpoint focuses on the peak value in a specified early post-transplant window, rather than an average over that period or a later clinical event.
The registry reports this endpoint in U/L and summarizes each arm using a geometric mean with a 95% confidence interval. In general, a geometric mean is suitable for positive measurements whose distribution is asymmetric, because it summarizes values on a multiplicative scale. The confidence interval conveys uncertainty around the arm-level estimate; it is not itself a direct estimate of the difference between arms.
The posted geometric mean is 1263.0 U/L for the combined drug arm, with a 95% confidence interval from 946.3 to 1685.0. For the control arm, the reported geometric mean is 1451.0 U/L, with a 95% confidence interval from 1087.0 to 1937.0. The registry defines the endpoint as the highest AST value within 72 hours, but does not report a comparative estimate, confidence interval, or p-value for the primary outcome.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary results are arm-level summaries, not a reported treatment-effect analysis. The combined drug arm has a geometric mean peak AST of 1263.0 U/L, while the control arm has a geometric mean of 1451.0 U/L. The 95% confidence intervals are 946.3 to 1685.0 and 1087.0 to 1937.0, respectively. These intervals overlap. The registry record does not report a direct estimate of the between-arm difference or a test of the primary endpoint, so the arm-level figures alone do not establish whether the observed contrast is statistically distinguishable from chance variation.
Confidence intervals describe uncertainty around the estimated arm-level geometric means under the analysis used. They do not give the probability that the true value lies within the interval, and separate arm-level intervals should not be treated as a substitute for a confidence interval on the treatment contrast. A formal comparison would need to account for the chosen scale and analysis model. The registry record does not report that comparison or enough analysis detail to reconstruct it.
The outcome numbers reported for the primary endpoint are 36 in each arm. The record does not explain how those numbers relate to the enrollment of 143, or whether missing measurements, eligibility for the endpoint, or another analysis-population rule accounts for the difference. That lack of explanation limits assessment of how representative the posted estimates are of all enrolled participants.
Some secondary outcomes have unadjusted comparisons and confidence intervals in the posted results, while no reported analyses are listed for those outcomes. These are exploratory evidence rather than a substitute for the primary analysis. Their interpretation should account for imprecision and the possibility of chance findings when several outcomes are considered. No sponsor-reported primary comparison is available in the registry record, and the record does not provide a trial-specific explanation of the analysis decisions.
These results describe the available registry record, not a conclusion about clinical benefit or harm. The primary outcome is a laboratory measure collected early after transplantation. It does not by itself establish what happened to longer-term graft outcomes, survival, or other clinical endpoints. Those outcomes require their own reported estimates, analysis details, and context.
9. Statistical Methods Explained
The registry identifies random allocation, single masking, and a parallel model. These design features describe how the comparison was organized, but do not fully specify the analysis. The record does not report the allocation-generation method, concealment procedures, who was masked, or a detailed statistical plan. Without those details, the posted estimates can be described, but the analysis cannot be fully assessed against a prespecified plan.
What does a geometric mean summarize?
In general, a geometric mean summarizes positive measurements by averaging on a logarithmic scale and then returning to the original scale. It is often used when measurements are skewed or when proportional changes are more meaningful than equal absolute changes. Its interpretation differs from that of an arithmetic mean: it represents a central value on a multiplicative scale. The registry specifies a geometric mean and 95% confidence interval for peak AST, but does not report the transformation, estimation procedure, or model used to calculate them.
The combined drug arm's posted geometric mean is 1263.0 U/L, with limits of 946.3 and 1685.0. The control arm's geometric mean is 1451.0 U/L, with limits of 1087.0 and 1937.0. In general, a 95% confidence interval expresses the uncertainty of an estimate under repeated use of the specified method. It should not be read as a range containing 95% of individual participants' AST values. The registry calls these intervals confidence intervals, not individual-level ranges.
Why is the primary comparison not recoverable from arm summaries?
A treatment comparison is usually expressed as a contrast between arms, with its own estimate and uncertainty. For a geometric-mean endpoint, that contrast may use a ratio or a difference on the log scale, depending on the analysis plan. Separate arm estimates and intervals do not supply the covariance or model information needed for every possible contrast. The record posts neither a primary between-arm estimate nor its confidence interval or p-value. Consequently, it is not appropriate to calculate a primary contrast from the arm-level summaries and present it as the trial's analysis.
The posted secondary binary outcomes include counts and unadjusted risk-difference estimates. A risk difference expresses the contrast in outcome probabilities on an absolute scale. Its confidence interval gives a range of values compatible with the data and method, subject to the assumptions of that method. When such an interval includes zero, the data are compatible with no absolute difference as well as with effects in either direction covered by the interval. The reported unadjusted p-values test a null hypothesis under the specific method used; they do not measure the probability that the null hypothesis is true, nor do they describe the size or clinical importance of an effect.
Relative measures, such as risk ratios and odds ratios, express contrasts on different scales. In general, a ratio of one represents no relative contrast, while a difference of zero represents no absolute contrast. Relative and absolute measures can tell different parts of the same story, particularly when outcome probabilities are not high. These measures are useful for interpretation, but the record does not report adjusted analyses for the listed secondary outcomes.
Why can over-dispersion matter?
In general, over-dispersion occurs when observed variability is greater than a statistical model assumes. If a model does not allow for that extra variability, its uncertainty estimates may be too narrow and its tests may be overly optimistic. This concept is relevant when outcomes are counts or when participant responses vary more than a simple model anticipates. The posted primary endpoint is a positive laboratory measurement summarized by a geometric mean, and the record does not identify the model or discuss over-dispersion. It is therefore not possible to determine from the registry record whether this issue was assessed or relevant to the sponsor's primary analysis.
The planning illustrations accompanying the posted secondary comparisons are based on the observed effect, with assumptions of a two-sided significance level of 0.05, equal allocation, and a normal approximation. They illustrate sample sizes for specified fractions of the observed effect; they are not the trial's original design justification and are not observed power. In general, using an effect estimated from a small study as the planning target can yield unstable projections. Smaller target effects require larger samples under otherwise comparable assumptions. The registry record does not report its own sample-size justification or the assumptions used in the original design.
The record lists zero reported analyses and has no reported analysis entries for the secondary comparisons. The simple unadjusted calculations included in the posted results should therefore be distinguished from sponsor-reported analyses. The registry record does not describe whether the analyses were prespecified, whether they were adjusted for baseline variables, how missing data were handled, or which population was used. These omissions matter because the analysis population, model, and handling of incomplete observations can affect estimates and uncertainty.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome and 10 secondary outcomes. Considering several outcomes raises the issue of multiplicity: even when each test uses a conventional significance threshold, the chance of at least one chance-positive finding can increase across a collection of tests. In general, analysis plans may address this by specifying a hierarchy, adjusting the threshold, or distinguishing confirmatory from exploratory outcomes. The registry record does not report a multiplicity strategy, an outcome hierarchy, or a statistical analysis plan that would clarify how the family of outcomes was handled.
The secondary comparisons are unadjusted, and the record does not report adjusted analyses. Their p-values should therefore be interpreted as individual, unadjusted tests rather than as evidence that accounts for the full set of outcomes. The absence of a reported multiplicity procedure does not prove that none was used outside the registry record; it means that the record does not document one.
Missing-data methods are also not reported in the registry record. It does not state how incomplete AST measurements or missing secondary outcome data were handled, whether any imputation was used, or how follow-up losses were treated. The arm-level primary outcome numbers are 36 per group, while enrollment is reported as 143; the record does not explain the relationship between those figures. It is not possible to infer the reasons or the consequences for the estimates.
The analysis populations are not described. The registry record does not say whether the posted outcomes use an intention-to-treat population, a per-protocol population, or another defined group, nor does it report exclusions by arm. Such information is important in a randomized trial because the population included in analysis can affect how closely estimates reflect the randomized comparison. The record also does not report interim analyses, stopping rules, or a sample-size justification. These features should be treated as undocumented rather than assumed absent or present.
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 |
|---|---|---|---|
| Combined Drug Approach | 6 | 36 | 16.7% |
| Controles | 4 | 36 | 11.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Combined Drug Approach | 4 of 36 |
| Controles | 3 of 36 |
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 |
|---|---|
| Combined Drug Approach | 33 of 36 |
| Controles | 31 of 36 |
Most frequent serious adverse event terms
| Event term | Organ system | Combined Drug Approach | Controles |
|---|---|---|---|
| General surgical complications | Surgical and medical procedures | 2 of 36 | 2 of 36 |
| Respiratory insufficiency | Respiratory, thoracic and mediastinal disorders | 1 of 36 | 1 of 36 |
| Kidney dysfunction | Renal and urinary disorders | 1 of 36 | 0 of 36 |
| Bacterial infection | Infections and infestations | 1 of 36 | 0 of 36 |
| Arrythmia | Cardiac disorders | 1 of 36 | 0 of 36 |
| Portal vein thrombosis | Surgical and medical procedures | 0 of 36 | 1 of 36 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Combined Drug Approach | Controles |
|---|---|---|---|
| Surgical complications - general | Injury, poisoning and procedural complications | 22 of 36 | 18 of 36 |
| Bacterial infections | Infections and infestations | 16 of 36 | 10 of 36 |
| Acute kidney injury | Renal and urinary disorders | 12 of 36 | 9 of 36 |
| Post-operative delirium | General disorders | 9 of 36 | 11 of 36 |
| Rejections | Immune system disorders | 6 of 36 | 6 of 36 |
| Organ specific complications | Hepatobiliary disorders | 5 of 36 | 6 of 36 |
| Biliary problems | Hepatobiliary disorders | 6 of 36 | 5 of 36 |
| Cardiovascular events | Cardiac disorders | 2 of 36 | 6 of 36 |
| Urinary tract infections | Renal and urinary disorders | 2 of 36 | 5 of 36 |
| Viral infections | Infections and infestations | 6 of 36 | 1 of 36 |
Serious events with the highest arm-level rate: general surgical complications (5.6%), respiratory insufficiency (2.8%), kidney dysfunction (2.8%), bacterial infection (2.8%), arrythmia (2.8%).
The safety figures describe adverse-event reporting in the registry, not a causal comparison of the treatments. For serious adverse events, the record reports 6 affected among 36 at risk in the combined drug group and 4 affected among 36 at risk in the control group. For other adverse events, it reports 33 affected among 36 at risk in the combined drug group and 31 affected among 36 at risk in the control group. Deaths are reported as 4 and 3, respectively. These counts do not by themselves establish that an event was caused by the assigned treatment.
The listed serious-event terms include general surgical complications at 5.6%, and respiratory insufficiency, kidney dysfunction, bacterial infection, arrythmia, and portal vein thrombosis at 2.8% each. The registry record does not provide a detailed accounting of event timing, severity grading beyond the serious classification, recurrence, or attribution by investigators. It also does not report confidence intervals or a formal comparative safety analysis.
Safety counts are descriptive and should be considered alongside the size and follow-up of the groups and the completeness of event collection. Without those details, differences in counts should not be interpreted as proof of a treatment-related increase or decrease in risk.
12. What the Result Does, and Does Not, Mean
The registry record supports a descriptive statement about the posted primary outcome: the combined drug arm has a lower arm-level geometric mean peak AST than the control arm, while the confidence intervals around the arm-level estimates overlap. It does not report a primary treatment-effect estimate, confidence interval for that contrast, or p-value. The direction of the arm summaries is not enough to determine whether the groups differ beyond chance variation.
The record also does not establish that the combined approach reduces ischemia-reperfusion injury, nor does it establish that it has no effect. A lack of a reported primary comparison is not evidence of equivalence. To assess the primary question, readers would need the prespecified contrast, its uncertainty, and the analysis details, including the population analyzed and the handling of missing measurements.
The secondary outcomes broaden the clinical picture but are limited by the absence of reported analyses for the full set and by unadjusted comparisons. They cannot be treated as definitive evidence of differences in graft outcomes, biliary events, rejection, or survival. The serious and other adverse-event counts are descriptive; they do not establish attribution or comparative safety.
The design was randomized, which is an important feature for reducing confounding in a comparison, but the record does not report enough detail to assess allocation procedures, masking, analysis populations, or the statistical plan. Its enrollment figure and the primary outcome arm numbers are not reconciled in the record. These limitations mean that the findings should be interpreted as incomplete registry reporting rather than as a complete account of the trial's evidence.
Finally, peak AST is an early biochemical endpoint. Even a well-estimated difference in that measure would not, on its own, establish a difference in longer-term graft function, recipient outcomes, or overall clinical benefit. Each of those questions requires adequately reported outcome data and a suitable analysis.
13. Why This Trial Matters Statistically
This trial is statistically notable because the registry provides arm-level estimates for its primary laboratory endpoint without reporting the direct comparison that addresses the central question. The distinction between describing each group and estimating the difference between groups is fundamental. The arm summaries give useful information about the observed values and their uncertainty, but they cannot replace an effect estimate with uncertainty for the randomized contrast.
The trial also illustrates why outcome definitions and scales matter. Peak AST is summarized as a geometric mean, whereas several secondary outcomes are binary counts with unadjusted risk differences and relative measures. Each scale answers a different question, and the method used to estimate uncertainty should correspond to the outcome and analysis plan. A single numerical summary cannot represent the full range of laboratory, graft, safety, and survival outcomes.
Planning illustrations based on observed effects can help readers understand how imprecise estimates from a trial might inform future study planning. They are not a substitute for the original sample-size justification, and they are not observed power. The record does not state the original design assumptions, so the planning illustrations should be understood only under their stated assumptions.
The record highlights reporting issues that affect reproducibility: the relationship between enrollment and the primary endpoint numbers is unexplained, analysis populations and missing-data methods are not described, and multiplicity handling is not reported. Clear reporting of these elements would help readers evaluate the precision and reliability of both primary and secondary findings. These points are relevant beyond this trial because they distinguish a result that can be independently interpreted from one that remains largely descriptive.
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.
Several trial-specific limitations arise from the registry record. Although the study is marked completed and gives arm-level AST estimates, it does not report a direct primary comparison. The uncertainty intervals around each arm's estimate do not supply the missing contrast, and the record offers no p-value for the primary endpoint. This leaves the main statistical question unresolved in the registry reporting.
The relationship between enrollment of 143 and the primary outcome numbers of 36 in each arm is not explained. The record does not state whether this reflects missing measurements, an analysis subset, or another reason, so no explanation should be assumed. Eligibility criteria, baseline characteristics, and analysis-population definitions are also not reported in the record, limiting assessment of representativeness and comparability.
Design and analysis details are sparse. Randomization and single masking are identified, but the record does not say who was masked or describe the allocation method. It does not report the trial's sample-size justification, its statistical analysis plan, missing-data procedures, interim analyses, or a multiplicity strategy. Without those details, readers cannot determine whether the posted analyses match prespecified methods or how outcome selection and incomplete observations were addressed.
The intervention is a combination, so the comparison does not isolate individual drug components. The registry record also does not provide enough detail about administration to assess the contribution of timing or dosing. Secondary results are unadjusted and incompletely analyzed in the record; safety information is descriptive and lacks a reported formal comparison. These limitations concern what can be learned from the posted record and should not be taken to imply what the full study team may have analyzed elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL) — NCT02251041.
- Registry record last updated 2024-08-23; status last verified 2015-12.
- Results first posted 2024-08-23.
- 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
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18. Record Summary
The registry record describes CAPITL, a randomized, single-masked, parallel phase 2 study of a combined drug approach versus placebo during liver transplantation. It is marked completed, with enrollment of 143, study start in 2014-09, and primary completion in 2019-02. The primary endpoint is peak serum AST within 72 hours following transplantation, summarized by arm as a geometric mean with a 95% confidence interval.
The posted primary outcome numbers are 36 per arm. The record does not report a primary between-arm estimate or statistical test, and it does not explain how the endpoint numbers relate to enrollment. Secondary outcomes cover graft, biliary, rejection, and safety measures, but the record does not provide a complete reported analysis. Missing-data methods, analysis populations, the original sample-size justification, and multiplicity handling are not reported in the registry record.