Effect of Oral Cimetidine in the Protoporphyrias
Model scores of the 29,894 trials active now.
Model score 9% 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
Completed on 2025-04-24, after 2022-06-14 start.
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 2025-04-24. 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
-
Design: crossover (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: transplantto determinemarrowlifeenrollment
Phrases that lowered it: and safetyparticipantefficacy andparticipantsmoderate -
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Responsible party: sponsor investigator (raises risk) · Design
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Phase: 2 (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 13.2% (lowers risk) · Drug's FDA history
-
Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: Yes (raises risk) · Design
-
Collaborators: 2 (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Number of arms: 2 (raises 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
-
Disease area, neurology: No (lowers risk) · Disease area
-
Drug's FAERS reports before start: 9151 (raises risk) · Drug's FDA history
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Minimum age: 15 (raises risk) · Who can join
-
Sponsor's past trials: 0 (lowers 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.
The trial
Design
- Phase
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 15 (typical: 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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 9151 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 587 (typical: 412.5)
- Drug's FAERS reports marked serious
- 82.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 13.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive, metabolic, dermatology
- Drugs matched to FDA substances
- cimetidine
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
- Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and PPIX Concentrations in Participants With EPP NCT05308472 · started 2022 · scored riskier than 15% of active trials completed
- Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoietic Protoporphyria NCT03520036 · started 2018 · scored riskier than 17% of active trials completed
- Controlled Trial of Panhematin in Treatment of Acute Attacks of Porphyria NCT02180412 · started 2014 · scored riskier than 70% of active trials completed
- Sorbent Therapy of the Cutaneous Porphyrias NCT01422915 · started 2011 · scored riskier than 9% of active trials completed
- GATEWAY: A Phase 2a Study of PORT-77 in Adults With Erythropoietic Protoporphyria NCT06971900 · started 2025 · scored riskier than 11% 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.