Phase 3 Study of Bezafibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
Model scores of the 29,894 trials active now.
Model score 29% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (741 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.
How it ended
Completed on 2016-12-31, after 2012-10-15 start.
The score above never used this outcome: 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.
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 2016-12-31. 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.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: patientpatientstherapytreatedfailure
Phrases that lowered it: kgalcoholtestspositiveconsumption -
Sponsor's past termination rate: 21.1% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Blinding: quadruple (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 150 (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Drug's FAERS reports marked serious: 97.8% (raises risk) · Drug's FDA history
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Sponsor's past trials: 270 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 12.0% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Collaborators: 0 (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 88 (raises 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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 270 (typical: 32)
- Sponsor's past termination rate
- 21.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 150 (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
- 449 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 88 (typical: 412.5)
- Drug's FAERS reports marked serious
- 97.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- bezafibrate
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
- Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis NCT02823353 · started 2016 · scored riskier than 42% of active trials completed
- Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC NCT05239468 · started 2022 · scored riskier than 36% of active trials completed
- Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC NCT04594694 · started 2019 · scored riskier than 20% of active trials terminated
- Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis NCT05450887 · started 2021 · scored riskier than 16% of active trials completed
- Ursodeoxycholic Acid Plus Budesonide Versus Ursodeoxycholic Acid Alone in Primary Biliary Cirrhosis (PBC) NCT00746486 · started 2009 · scored riskier than 27% 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.