Comparison · NCT04168385-sae
Maralixibat: ALGS vs Maralixibat: PFIC: serious adverse events
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. Maralixibat: ALGS vs Maralixibat: PFIC: serious adverse events. Trial comparisons, record NCT04168385-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04168385-sae
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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 | 0.25 | 0.142 | 0.402 | wilson | |
| Risk in group 2 | 0.25 | 0.0889 | 0.532 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.302 | 0.221 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.327 | 3.06 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.225 | 4.44 | log | |
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Maralixibat: ALGS | Participants will all receive Maralixibat oral solution~Maralixibat chloride oral solution orally twice daily Up to 1.2\* mg/kg/day), and according to indication.~\*equivalent to 1.14 mg/kg/day maralixibat. Doses reported here are in maralixibat chloride.~Participants with ALGS received maralixibat doses in the range of 0.15 mg/kg QD to 0.45 mg/kg BID. | 10 | 40 | EG000 |
| Group 2 | Maralixibat: PFIC | Participants will all receive Maralixibat oral solution~Maralixibat chloride oral solution orally twice daily Up to 1.2\* mg/kg/day), and according to indication.~\*equivalent to 1.14 mg/kg/day maralixibat. Doses reported here are in maralixibat chloride.~Participants with PFIC received maralixibat doses in the range of 0.3 mg/kg QD to 0.6 mg/kg BID. | 3 | 12 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- The timeframe for reporting adverse events was from informed consent through approximately 4.5 years, including 30 days after last dose.
Source ClinicalTrials.gov
Trial
- Title
- MRX-800: A Long-Term Safety Study of Maralixibat in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study
- NCT number
- NCT04168385
- Phases
- PHASE2
- Conditions
- Cholestatic Liver Disease
- Interventions
- Maralixibat
- Lead sponsor
- Mirum Pharmaceuticals, Inc.
- Results first posted
- 2025-12-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04168385?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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