An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)

Model scores of the 29,894 trials active now.

Model score 23% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 17% of the time (213 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2025-04-23. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: the subjectlong termterm safetythe longextension study
  Phrases that lowered it: safety ofvisitevaluate thediseasesopen label
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 3 (lowers risk) · Design
• Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
• Has a data monitoring committee: Yes (raises risk) · Design
• Design: single group (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor's past termination rate: 9.1% (raises risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Maximum age: 18 (raises risk) · Who can join
• Sponsor's past trials: 11 (lowers risk) · Sponsor's track record
• Keywords listed: 10 (lowers risk) · Design
• Number of arms: 1 (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

• 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 NCT04168385 · started 2020 · scored riskier than 90% of active trials completed
• A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS). NCT04729751 · started 2021 · scored riskier than 17% of active trials completed
• A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC) NCT03905330 · started 2019 · scored riskier than 55% of active trials completed
• An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS) NCT02047318 · started 2013 · scored riskier than 86% of active trials completed
• Open Label Study to Evaluate Efficacy and Long Term Safety of LUM001 (Maralixibat) in the Treatment of Cholestatic Liver Disease in Patients With Progressive Familial Intrahepatic Cholestasis NCT02057718 · started 2014 · scored riskier than 33% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.