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)

Model scores of the 29,894 trials active now.

Model score 24% 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 20% of the time (389 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2020-06-17. 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: long termterm safetythe longextensioncompleted
  Phrases that lowered it: patients whoweeksefficacyperiodeffect
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 2 (raises risk) · Design
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Design: single group (raises risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Maximum age: 18 (raises risk) · Who can join
• Number of arms: 1 (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Blinding: none (raises risk) · Design
• Drug's FAERS reports before start: 0 (raises risk) · Drug's FDA history
• Drug's FAERS reports in the prior 12 months: 0 (raises risk) · Drug's FDA history
• Sponsor's past trials: 2 (lowers risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• Collaborators: 0 (raises risk) · Design
• Sponsor type: industry (lowers 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.

• An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome NCT02117713 · started 2015 · scored riskier than 77% of active trials completed
• Safety and Efficacy Study of LUM001 (Maralixibat) With a Drug Withdrawal Period in Participants With Alagille Syndrome (ALGS) NCT02160782 · started 2014 · scored riskier than 39% of active trials completed
• Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome NCT01903460 · started 2013 · scored riskier than 14% of active trials completed
• An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC) NCT04185363 · started 2020 · scored riskier than 83% 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

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.