Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment

Model scores of the 29,894 trials active now.

Model score 23% for any early termination, 3% 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 2023-09-15. 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: stageevidenceacuteinjurydisease
  Phrases that lowered it: the effecteffect ofmgdayevaluate the
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 20% (raises risk) · Sponsor's track record
• Design: parallel (raises risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Blinding: quadruple (lowers risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Sponsor's past trials: 5 (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Number of arms: 3 (lowers risk) · Design
• Maximum age: 85 (lowers risk) · Who can join
• Phase: 3 (lowers risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Collaborators: 0 (raises risk) · Design
• Keywords listed: 1 (raises risk) · Design

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.

• Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis NCT03439254 · started 2017 · scored riskier than 49% of active trials completed
• A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH) NCT04767529 · started 2021 · scored riskier than 16% of active trials completed
• Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH) NCT04929483 · started 2021 · scored riskier than 15% of active trials completed
• Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis NCT02217475 · started 2014 · scored riskier than 14% of active trials completed
• A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis NCT04171765 · started 2020 · scored riskier than 26% of active trials terminated

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.