Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)

NCT01017575 on ClinicalTrials.gov Phase 2 Bristol-Myers Squibb (industry) Started 2009-12-31 Completed

Riskier than 6% of active trials

Model scores of the 29,894 trials active now.

Model score 6% 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 8% of the time (780 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 2011-10-31, after 2009-12-31 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 2011-10-31. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: keystandardsafetreatmenttolerated
Phrases that lowered it: genotypehcvribavirinhepatitis virusjapanese
Minimum age: 20 (lowers risk) · Who can join
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Drug's FAERS reports with a death: 9.3% (lowers risk) · Drug's FDA history
Number of arms: 5 (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Trials the sponsor started in the prior 2 years: 112 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Sponsor's past termination rate: 7.7% (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Design: parallel (raises risk) · Design
Blinding: quadruple (lowers risk) · Design
Maximum age: 70 (lowers risk) · Who can join
Drug's FAERS reports marked serious: 96.4% (raises risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Sponsor's past trials: 222 (lowers risk) · Sponsor's track record
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: 2
Number of arms: 5 (typical: 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: 20 (typical: 18)
Maximum age: 70 (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: 222 (typical: 32)
Sponsor's past termination rate: 7.7% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 112 (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: 9147 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1707 (typical: 412.5)
Drug's FAERS reports marked serious: 96.4% (typical: 85.6%)
Drug's FAERS reports with a death: 9.3% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease, digestive
Drugs matched to FDA substances: daclatasvir, peginterferon alfa2a, ribavirin

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

Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients NCT01016912 · started 2009 · scored riskier than 7% 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
Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients NCT01125189 · started 2010 · scored riskier than 22% of active trials completed
Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy NCT01718158 · started 2013 · scored riskier than 12% of active trials completed
A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection NCT02496078 · started 2015 · scored riskier than 20% 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.