Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis
Model scores of the 29,894 trials active now.
Model score 12% 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 26% of the time (136 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2025-02-20, after 2017-08-16 start.
Reason given by the sponsor: “enrollment”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2025-02-20. 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.
What moved the score
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: chronic kidneykidney diseaseliverrandomizationmonths
Phrases that lowered it: participantsparticipantefficacy andand safetydiseases -
Sponsor's past termination rate: 11.5% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: 9.0% (lowers risk) · Drug's FDA history
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 57 (lowers risk) · Sponsor's track record
-
Collaborators: 2 (lowers risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Responsible party: principal investigator (lowers risk) · Design
-
Drug's FAERS reports marked serious: 78.2% (lowers risk) · Drug's FDA history
-
Has a data monitoring committee: No (lowers risk) · Design
-
Number of arms: 2 (raises risk) · Design
-
Drug's FAERS reports before start: 78 (lowers risk) · Drug's FDA history
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.
The trial
Design
- Phase
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- 75 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 61 (typical: 32)
- Sponsor's past termination rate
- 11.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 57 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 78 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 29 (typical: 412.5)
- Drug's FAERS reports marked serious
- 78.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- berberine
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- JKB-121 for the Treatment of Nonalcoholic Steatohepatitis NCT02442687 · started 2015 · scored riskier than 22% 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
- Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH) NCT01694849 · started 2012 · scored riskier than 22% of active trials completed
- Effect of LIK066 on Reduction of Fatty Content in Livers of Obese Patients NCT03205150 · started 2017 · scored riskier than 70% of active trials completed
- A Study in Participants With Non-cirrhotic NASH With Fibrosis NCT05638737 · started 2022 · scored riskier than 68% 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.