A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients

NCT03780543 on ClinicalTrials.gov Phase 2 Assembly Biosciences (industry) Started 2018-12-20 Terminated

Riskier than 49% of active trials

Model scores of the 29,894 trials active now.

Model score 16% 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 8% of the time (780 trials).

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

How it ended

Terminated on 2021-04-26, after 2018-12-20 start.

Reason given by the sponsor: “business”

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 2021-04-26. 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) (raises risk) · Wording Phrases that raised it: subjectchronicextension studyrequiringinsulin
Phrases that lowered it: to evaluateevaluate theinvestigatormale orefficacy
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 10.6% (lowers risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
Number of arms: 3 (lowers risk) · Design
Drug's FAERS reports marked serious: 81.4% (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, neurology: No (lowers risk) · Disease area
Blinding: none (raises risk) · Design
Drug's FAERS reports before start: 42459 (lowers risk) · Drug's FDA history
Drugs with FDA adverse-event history: 4 (lowers risk) · Drug's FDA history
Sponsor's past trials: 2 (raises risk) · Sponsor's track record

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: 3 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 7 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 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: 2 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 4 (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: 42459 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 7027 (typical: 412.5)
Drug's FAERS reports marked serious: 81.4% (typical: 85.6%)
Drug's FAERS reports with a death: 10.6% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease, digestive
Drugs matched to FDA substances: entecavir, tenofovir, tenofovir alafenamide, tenofovir disoproxil

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 Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors NCT04454567 · started 2020 · scored riskier than 26% of active trials terminated
A Study Evaluating ABI-H0731-containing Regimens in Chinese Participants With Chronic Hepatitis B Virus Infection NCT04781647 · started 2021 · scored riskier than 24% of active trials terminated
A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection NCT03576066 · started 2018 · scored riskier than 40% of active trials completed
A Study Evaluating Treatment Regimens Containing Vebicorvir (ABI-H0731) in Participants With Chronic Hepatitis B Infection NCT04820686 · started 2021 · scored riskier than 25% of active trials terminated
Clinical Efficacy of ABX203 Therapeutic Vaccine in HBeAg Negative Patients With Chronic Hepatitis B NCT02249988 · started 2014 · scored riskier than 50% 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.