A Pilot Study of Xifaxan to Treat Patients With PSC
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (81 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 2014-03-31, after 2012-08-31 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 2014-03-31. 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: patientpatientssurvivaltransplantprimary
Phrases that lowered it: kgweightstudyalcoholdaily -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 14.4% (raises risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Drug's FAERS reports marked serious: 65.0% (lowers risk) · Drug's FDA history
-
Design: single group (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 132 (lowers risk) · Sponsor's track record
-
Sponsor's past trials: 369 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 10.1% (lowers risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
-
Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Responsible party: principal investigator (lowers risk) · Design
-
Drug's FAERS reports in the prior 12 months: 166 (raises risk) · Drug's FDA history
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Collaborators: 0 (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.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 2 (typical: 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
- 369 (typical: 32)
- Sponsor's past termination rate
- 14.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 132 (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
- 563 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 166 (typical: 412.5)
- Drug's FAERS reports marked serious
- 65.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- rifaximin
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
- Vancomycin for Primary Sclerosing Cholangitis NCT03710122 · started 2020 · scored riskier than 87% of active trials terminated
- Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis NCT02943460 · started 2016 · scored riskier than 86% of active trials completed
- Vidofludimus Calcium for Primary Sclerosing Cholangitis NCT03722576 · started 2019 · scored riskier than 79% of active trials completed
- A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis NCT01085760 · started 2010 · scored riskier than 56% of active trials completed
- Study of Cilofexor in Adults With Primary Sclerosing Cholangitis NCT03890120 · started 2019 · scored riskier than 96% 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.