CM-101 in NASH Patients - The SPLASH Study

Model scores of the 29,894 trials active now.

Model score 25% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 18% of the time (280 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 2022-08-25. 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: stageevidencecmsurgerypatient
  Phrases that lowered it: kgbmibodymalealcohol
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Phase: 2 (raises risk) · Design
• Design: parallel (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Has a data monitoring committee: Yes (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Number of arms: 2 (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Collaborators: 0 (raises risk) · Design
• Maximum age: 75 (lowers risk) · Who can join
• Blinding: double (raises risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Sponsor's past trials: 3 (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.

• Phase 1 Study to Evaluate Safety of GR-MD-02 in Subjects With Non-Alcoholic Steatohepatitis (NASH) and Advanced Fibrosis NCT01899859 · started 2013 · scored riskier than 93% of active trials completed
• Emricasan, a Caspase Inhibitor, for Evaluation in Subjects With Non-Alcoholic Steatohepatitis (NASH) Fibrosis NCT02686762 · started 2016 · scored riskier than 89% of active trials completed
• The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis NCT04134091 · started 2019 · scored riskier than 39% of active trials completed
• The Study of Multiple Doses of CM-101 in Male and Female NAFLD (Nonalcoholic Fatty Liver Disease) and NAFLD/NASH (Nonalcoholic Steatohepatitis) Subjects NCT06044467 · started 2018 · scored riskier than 57% of active trials completed
• A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH. NCT04019561 · started 2019 · scored riskier than 72% 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.