A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (876 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2017-02-28, after 2015-08-31 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 2017-02-28. 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: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cells000carcinomaconfirmedinfection
Phrases that lowered it: inclusivevisitscreeningkgbmi -
Trials the sponsor started in the prior 2 years: 90 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 17.9% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 97.7% (raises risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Blinding: quadruple (lowers risk) · Design
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Sponsor's past termination rate: 10.2% (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, infectious disease: Yes (lowers risk) · Disease area
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Number of arms: 2 (raises risk) · Design
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Responsible party: sponsor (lowers 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
- 3 (typical: 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
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (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
- industry (typical: academic or other)
- Sponsor's past trials
- 501 (typical: 32)
- Sponsor's past termination rate
- 10.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 90 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 480 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 340 (typical: 412.5)
- Drug's FAERS reports marked serious
- 97.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 17.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, digestive
- Drugs matched to FDA substances
- asunaprevir, daclatasvir
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
- Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives) NCT01581203 · started 2012 · scored riskier than 9% of active trials completed
- UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C NCT02123654 · started 2014 · scored riskier than 10% of active trials completed
- A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1 NCT02170727 · started 2014 · scored riskier than 25% of active trials completed
- Safety and Efficacy Study of the Combination Daclatasvir (60 mg), Sofosbuvir (400 mg) and Ribavirin (Weight-based Dosing) for 12 or 16 Weeks in Subjects With Genotype 3 Chronic HCV Infection With or Without Prior Treatment Experience and Advanced Fibrosis or Compensated Cirrhosis NCT02319031 · started 2015 · scored riskier than 12% of active trials completed
- Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin) NCT00874770 · started 2009 · scored riskier than 9% 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.