A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1)

NCT02265237 on ClinicalTrials.gov Phase 3 AbbVie (industry) Started 2014-10-28 Completed

Riskier than 16% of active trials

Model scores of the 29,894 trials active now.

Model score 10% 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 2017-04-07, after 2014-10-28 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 2017-04-07. 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

Accepts healthy volunteers: No (raises risk) · Who can join
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: priorpurpose ofthe purposeinfectioninfected
Phrases that lowered it: participanthcvopen labelreceiptparticipants
Sponsor's past termination rate: 3.7% (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 69 (lowers risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Design: parallel (raises risk) · Design
Drug's FAERS reports with a death: 6.9% (lowers risk) · Drug's FDA history
Drug's FAERS reports marked serious: 71.6% (lowers risk) · Drug's FDA history
Number of arms: 4 (lowers risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Disease area, infectious disease: Yes (lowers risk) · Disease area
Drug's FAERS reports before start: 54716 (raises risk) · Drug's FDA history
Disease area, neurology: No (lowers risk) · Disease area

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: 4 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 4 (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: 27 (typical: 32)
Sponsor's past termination rate: 3.7% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 69 (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: 54716 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 8645 (typical: 412.5)
Drug's FAERS reports marked serious: 71.6% (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: 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

Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults NCT02493855 · started 2015 · scored riskier than 7% of active trials completed
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis NCT02219503 · started 2014 · scored riskier than 23% of active trials completed
A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults NCT02582632 · started 2015 · scored riskier than 6% of active trials completed
Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study NCT02939989 · started 2016 · scored riskier than 7% of active trials completed
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil NCT02442271 · started 2015 · scored riskier than 8% 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.