A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection

NCT05123599 on ClinicalTrials.gov Phase 1 Janssen Research & Development, LLC (industry) Started 2021-12-06 Completed

Riskier than 32% of active trials

Model scores of the 29,894 trials active now.

Model score 13% for any early termination, 2% 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 (776 trials).

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

How it ended

Completed on 2024-06-26, after 2021-12-06 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 2024-06-26. 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

Accepts healthy volunteers: No (raises risk) · Who can join
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: of screeningtime ofleast monthsto assessto screening
Phrases that lowered it: participantsparticipantevaluate theopen labelto evaluate
Phase: 1 (lowers risk) · Design
Sponsor's past termination rate: 10.0% (raises risk) · Sponsor's track record
Drug's FAERS reports with a death: 6.6% (lowers risk) · Drug's FDA history
Design: single group (raises risk) · Design
Trials the sponsor started in the prior 2 years: 123 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports before start: 66172 (lowers risk) · Drug's FDA history
Blinding: none (lowers risk) · Design
Drug's FAERS reports marked serious: 86.5% (lowers 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: 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: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 60 (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: 491 (typical: 32)
Sponsor's past termination rate: 10.0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 123 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 2 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 66172 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 6564 (typical: 412.5)
Drug's FAERS reports marked serious: 86.5% (typical: 85.6%)
Drug's FAERS reports with a death: 6.6% (typical: 15.9%)

Disease area and drugs

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

An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection NCT03361956 · started 2018 · scored riskier than 60% of active trials completed
An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants NCT05275023 · started 2022 · scored riskier than 33% of active trials completed
A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection NCT04585789 · started 2021 · scored riskier than 28% of active trials completed
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of RO7062931in Healthy Volunteers and Subjects With Chronic Hepatitis B NCT03038113 · started 2017 · scored riskier than 10% of active trials completed
A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection NCT04129554 · started 2019 · scored riskier than 13% 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.