Evaluation of Safety, Tolerability, and Antiviral Activity of ACH-0143102 Plus Ribavirin In Treatment-naive Hepatitis C Virus Infection Genotype 1b Participants

NCT01700179 on ClinicalTrials.gov Phase 1 Alexion Pharmaceuticals, Inc. (industry) Started 2012-09-30 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 5% of the time (4,470 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 2013-09-30, after 2012-09-30 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 2013-09-30. 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: chronicdiseasediagnosismalignancyorgan
Phrases that lowered it: participantsribaviringenotypeevaluate theto evaluate
Sponsor's past termination rate: 28.0% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1 (lowers risk) · Design
Drug's FAERS reports with a death: 6.6% (lowers risk) · Drug's FDA history
Design: single group (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 75.8% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 11 (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Collaborators: 1 (raises risk) · Design
Drug's FAERS reports in the prior 12 months: 6554 (lowers risk) · Drug's FDA history

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: 1 (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: 1 (typical: 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: 25 (typical: 32)
Sponsor's past termination rate: 28.0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 11 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 13282 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 6554 (typical: 412.5)
Drug's FAERS reports marked serious: 75.8% (typical: 85.6%)
Drug's FAERS reports with a death: 6.6% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: 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, 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
Safety, Tolerability, and Efficacy of 12-weeks of Sovaprevir, ACH-3102, and Ribavirin in Treatment-naive GT-1 HCV Participants NCT01849562 · started 2013 · scored riskier than 17% of active trials completed
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Subjects With Genotype 1 Infection NCT02604017 · started 2015 · scored riskier than 6% of active trials completed
A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection NCT02966795 · started 2017 · scored riskier than 7% of active trials completed
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection NCT02243280 · started 2014 · scored riskier than 10% 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.