Hepatic Impairment Trial of Obeticholic Acid

Model scores of the 29,894 trials active now.

Model score 6% 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 5% of the time (4,470 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 2013-10-31. 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) (lowers risk) · Wording Phrases that raised it: classevidenceuncontrolledsubjectcell
  Phrases that lowered it: healthyvolunteershivthe trialsingle
• Accepts healthy volunteers: Yes (lowers risk) · Who can join
• Sponsor's past termination rate: 50% (raises risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Phase: 1 (lowers risk) · Design
• Design: single group (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Number of arms: 4 (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Primary purpose: basic science (raises risk) · Design
• Maximum age: not given (raises risk) · Who can join
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Blinding: none (lowers risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Sponsor's past trials: 2 (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
• Keywords listed: 0 (lowers 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.

• Single-Dose, Open-Label Pharmacokinetic Study of Bardoxolone Methyl in Subjects With Mild, Moderate, and Severe Hepatic Impairment and Normal Hepatic Function NCT01563562 · started 2012 · scored riskier than 4% of active trials completed
• PK and Safety in Participants Taking Obicetrapib With Moderate Hepatic Impairment Relative to Normal Hepatic Function NCT06048302 · started 2023 · scored riskier than 2% of active trials completed
• Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients NCT03765671 · started 2018 · scored riskier than 2% of active trials completed
• Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL) NCT02633956 · started 2015 · scored riskier than 48% of active trials completed
• Single Dose and Multiple Dose Trial to Assess Pharmacokinetics of Obeticholic Acid (OCA) NCT01933503 · started 2013 · scored riskier than 4% 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.