HepNet Pilot Trial: Multicenter Trial for the Treatment of Chronic Hepatitis E With Sofosbuvir (SofE)

NCT03282474 on ClinicalTrials.gov Phase 2 Hannover Medical School (academic or other) Started 2017-12-07 Completed

Riskier than 26% of active trials

Model scores of the 29,894 trials active now.

Model score 12% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (331 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2019-02-18, after 2017-12-07 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 2019-02-18. 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

Sponsor's past termination rate: 17.8% (raises risk) · Sponsor's track record
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: progesteronepostwomentherapyunless
Phrases that lowered it: screeningdrugmalethe investigatorrna
Accepts healthy volunteers: No (raises risk) · Who can join
Collaborators: 3 (lowers risk) · Design
Drug's FAERS reports marked serious: 50.8% (lowers risk) · Drug's FDA history
Phase: 2 (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Design: single group (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: 5.9% (lowers 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
Number of arms: 1 (raises risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Sponsor's past trials: 45 (lowers risk) · Sponsor's track record
Maximum age: not given (lowers risk) · Who can join
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: 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: 3 (typical: 0)
Keywords listed: 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: academic or other
Sponsor's past trials: 45 (typical: 32)
Sponsor's past termination rate: 17.8% (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: 31824 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 9395 (typical: 412.5)
Drug's FAERS reports marked serious: 50.8% (typical: 85.6%)
Drug's FAERS reports with a death: 5.9% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease, digestive
Drugs matched to FDA substances: sofosbuvir

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

Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir NCT03818308 · started 2019 · scored riskier than 17% of active trials completed
HepNet Acute HCV IV - LDV/SOF FDC in Acute Genotype 1 Hepatitis C Virus Infection NCT02309918 · started 2014 · scored riskier than 41% of active trials completed
A Phase II Trial of Sofosbuvir (SOF) and GS-5816 for People With Chronic Hepatitis C Virus Infection and Recent Injection Drug Use NCT02336139 · started 2016 · scored riskier than 59% of active trials completed
Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Participants With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis NCT02994056 · started 2017 · scored riskier than 21% of active trials completed
Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection NCT03312023 · started 2018 · scored riskier than 54% 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.