A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection

NCT02216422 on ClinicalTrials.gov Phase 3 AbbVie (industry) Started 2014-09-30 Completed

Riskier than 10% of active trials

Model scores of the 29,894 trials active now.

Model score 8% 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 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 2015-12-31, after 2014-09-30 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 2015-12-31. 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: carcinomaevidencetransplantchronicabt
Phrases that lowered it: participantand safetygenotypeefficacy andparticipants
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 4.2% (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 63 (lowers risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 6.8% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports marked serious: 71.4% (lowers risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Design: single group (raises risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Drug's FAERS reports before start: 53902 (raises risk) · Drug's FDA history
Disease area, infectious disease: Yes (lowers risk) · Disease area
Primary purpose: treatment (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: 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: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 5 (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: 24 (typical: 32)
Sponsor's past termination rate: 4.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 63 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 5 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 53902 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 8678 (typical: 412.5)
Drug's FAERS reports marked serious: 71.4% (typical: 85.6%)
Drug's FAERS reports with a death: 6.8% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease, digestive
Drugs matched to FDA substances: dasabuvir, ombitasvir, ombitasvir paritaprevir ritonavir, paritaprevir, 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

A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis NCT01704755 · started 2012 · scored riskier than 7% of active trials completed
A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection NCT02219490 · started 2014 · scored riskier than 10% of active trials completed
A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection NCT02167945 · started 2014 · scored riskier than 8% of active trials completed
ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients NCT01464827 · started 2011 · scored riskier than 5% of active trials completed
A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV) NCT01458535 · started 2011 · scored riskier than 5% 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.