Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection

NCT03074331 on ClinicalTrials.gov Phase 3 Gilead Sciences (industry) Started 2017-03-23 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 in 2015 or later: the model never saw it during training.

How it ended

Completed on 2018-02-07, after 2017-03-23 start.

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

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 2018-02-07. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: priorkeytransplantationcarcinomadefined
Phrases that lowered it: the efficacyhcvand safetyefficacy andevaluate the
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 14.3% (raises risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Drug's FAERS reports with a death: 9.3% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 104 (lowers risk) · Sponsor's track record
Design: single group (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports marked serious: 95.9% (raises risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Has a data monitoring committee: No (lowers risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Sponsor's past trials: 321 (lowers risk) · Sponsor's track record
Number of arms: 1 (raises risk) · Design
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: 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: 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: 321 (typical: 32)
Sponsor's past termination rate: 14.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 104 (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: 97 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 97 (typical: 412.5)
Drug's FAERS reports marked serious: 95.9% (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: sofosbuvir velpatasvir

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

Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV NCT02671500 · started 2016 · scored riskier than 6% of active trials completed
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection NCT02722837 · started 2016 · scored riskier than 10% of active trials completed
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection NCT02201940 · started 2014 · scored riskier than 8% of active trials completed
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis NCT02781558 · started 2016 · scored riskier than 7% of active trials completed
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis NCT04112303 · started 2019 · scored riskier than 6% 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.