Comparison · NCT04524390-3859128a
Double Blind - Maralixibat vs Double Blind - Placebo: Proportion of Participants Observed to Develop Clinically Evident Portal Hypertension Defined as Splenomegaly and Thrombocytopenia (Platelet Count <150 x 109/L) or Clinically Evident Ascites or Endoscopic Evidence of Esophageal or Gastric Varices.
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Double Blind - Maralixibat vs Double Blind - Placebo: Proportion of Participants Observed to Develop Clinically Evident Portal Hypertension Defined as Splenomegaly and Thrombocytopenia (Platelet Count <150 x 109/L) or Clinically Evident Ascites or Endoscopic Evidence of Esophageal or Gastric Varices. Trial comparisons, record NCT04524390-3859128a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04524390-3859128a
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.075 | 0.0258 | 0.199 | wilson | |
| Risk in group 2 | 0.114 | 0.0454 | 0.26 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0393 | -0.193 | 0.102 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.656 | 0.158 | 2.73 | log | |
| Odds ratio, group 1 over group 2 | 0.628 | 0.131 | 3.02 | log | |
| Number needed to treat, for one fewer participant with the outcome on Double Blind - Maralixibat than on Double Blind - Placebo | 25.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Double Blind - Maralixibat | The double-blind period comprised of 4-8 weeks of dose escalation followed by 18 - 22 weeks of stable dosing treatment, after which participants were transferred to the open-label arm. | 3 | 40 | OG000 |
| Group 2 | Double Blind - Placebo | The double-blind period comprised of 4-8 weeks of dose escalation followed by 18 - 22 weeks of stable dosing treatment, after which participants were transferred to the open-label arm. | 4 | 35 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
Proportion of Participants Observed to Develop Clinically Evident Portal Hypertension Defined as Splenomegaly and Thrombocytopenia (Platelet Count <150 x 109/L) or Clinically Evident Ascites or Endoscopic Evidence of Esophageal or Gastric Varices.
- Description
- Splenomegaly =\> (spleen size \>2 cm below the costal margin palpated on physical examination)
- Time frame
- From Baseline to Week 26
- Population
Source ClinicalTrials.gov
Trial
- Title
- Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai
- NCT number
- NCT04524390
- Phases
- PHASE2
- Conditions
- Biliary Atresia
- Interventions
- Maralixibat, Placebo
- Lead sponsor
- Mirum Pharmaceuticals, Inc.
- Results first posted
- 2025-02-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04524390?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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