Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects
Model scores of the 29,894 trials active now.
Model score 11% 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 19% of the time (90 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 2015-08-31, after 2012-01-31 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 2015-08-31. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cttherapyimagingpatients withbiopsy
Phrases that lowered it: oraltopicalallergystudypositive -
Sponsor's past termination rate: 12.3% (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 26.8% (raises risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
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Design: single group (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Minimum age: 1 (lowers risk) · Who can join
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Trials the sponsor started in the prior 2 years: 101 (lowers risk) · Sponsor's track record
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Sponsor's past trials: 243 (lowers risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Responsible party: principal investigator (lowers risk) · Design
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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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Drug's FAERS reports marked serious: 92.5% (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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 1 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 243 (typical: 32)
- Sponsor's past termination rate
- 12.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 101 (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
- 10186 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2157 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 26.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- vancomycin
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
- A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis NCT01085760 · started 2010 · scored riskier than 56% of active trials completed
- Vancomycin for Primary Sclerosing Cholangitis NCT03710122 · started 2020 · scored riskier than 87% of active trials terminated
- A Pilot Study to Characterize Bile Acid Metabolism and Dysbiosis in Primary Sclerosing Cholangitis NCT02464020 · started 2015 · scored riskier than 28% of active trials completed
- A POC and Dose-Ranging Study of HTD1801 in PSC Patients NCT03333928 · started 2018 · scored riskier than 69% of active trials completed
- Vidofludimus Calcium for Primary Sclerosing Cholangitis NCT03722576 · started 2019 · scored riskier than 79% 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.