A Study to Evaluate the Safety and Effect of Treatment With Experimental Antiviral Drugs in Combination With Peginterferon Alpha-2a and Ribavirin in People With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie/Abbott Combination Study

NCT01609933 on ClinicalTrials.gov Phase 2 AbbVie (prior sponsor, Abbott) (industry) Started 2012-12-18 Completed

Riskier than 12% of active trials

Model scores of the 29,894 trials active now.

Model score 9% 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 2017-05-03, after 2012-12-18 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 2017-05-03. 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: mrisubjectcarcinomapriorct
Phrases that lowered it: ribavirinrbvgenotypeto evaluateevaluate the
Accepts healthy volunteers: No (raises risk) · Who can join
Trials the sponsor started in the prior 2 years: 59 (lowers risk) · Sponsor's track record
Sponsor's past termination rate: 1.4% (lowers risk) · Sponsor's track record
Phase: 2 (raises risk) · Design
Drug's FAERS reports with a death: 6.9% (lowers risk) · Drug's FDA history
Design: single group (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Sponsor's past trials: 74 (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 67.7% (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Maximum age: 71 (lowers risk) · Who can join
Disease area, neurology: No (lowers risk) · Disease area
Number of arms: 1 (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: 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: sponsor
Collaborators: 0
Keywords listed: 4 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 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: 74 (typical: 32)
Sponsor's past termination rate: 1.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 59 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 4 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 56892 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 28211 (typical: 412.5)
Drug's FAERS reports marked serious: 67.7% (typical: 85.6%)
Drug's FAERS reports with a death: 6.9% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease, digestive
Drugs matched to FDA substances: interferon, ombitasvir, paritaprevir, peginterferon alfa2a, ribavirin, ritonavir

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

Oral Antivirals (GS-5885, Tegobuvir, and/or GS-9451) With Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection NCT01371578 · started 2011 · scored riskier than 12% of active trials completed
Safety, Tolerability, and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in Hepatitis C Virus (HCV) Positive Participants NCT01180790 · started 2010 · scored riskier than 16% of active trials completed
Efficacy and Safety of Grazoprevir (+) Uprifosbuvir (+) Ruzasvir (MK-3682B) (MK-5172 + MK-3682 + MK-8408) Fixed Dose Combination in Chronic HCV Participants Failing Prior Antiviral Treatment (MK-3682-021) NCT02613403 · started 2015 · scored riskier than 29% of active trials terminated
Safety, Tolerability and Efficacy of Sofosbuvir, Velpatasvir, and Voxilaprevir in Subjects With Previous DAA Experience NCT02745535 · started 2016 · scored riskier than 41% of active trials completed
HIV Patients With Chronic Hepatitis C Genotype 1 Infection Who Failed Previously to Peginterferon /Ribavirin NCT01718301 · started 2013 · scored riskier than 14% 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.