A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

NCT04667104 on ClinicalTrials.gov Phase 2 Janssen Research & Development, LLC (industry) Started 2021-02-01 Completed

Riskier than 20% of active trials

Model scores of the 29,894 trials active now.

Model score 11% 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

Completed on 2023-04-17, after 2021-02-01 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 2023-04-17. 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: chronicinterferonmonths priortreatment withevidence
Phrases that lowered it: jnjpharmacokineticsparticipantsto evaluatesafety tolerability
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 9.9% (raises risk) · Sponsor's track record
Phase: 2 (raises risk) · Design
Design: single group (raises risk) · Design
Drug's FAERS reports with a death: 7.0% (lowers risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Trials the sponsor started in the prior 2 years: 100 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Blinding: none (lowers risk) · Design
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Maximum age: 65 (raises risk) · Who can join
Disease area, neurology: No (lowers risk) · Disease area
Drug's FAERS reports before start: 85045 (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: 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: 65 (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: 453 (typical: 32)
Sponsor's past termination rate: 9.9%
Trials the sponsor started in the prior 2 years: 100 (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: 85045 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 31045 (typical: 412.5)
Drug's FAERS reports marked serious: 83.9% (typical: 85.6%)
Drug's FAERS reports with a death: 7.0% (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 of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection NCT04439539 · started 2020 · scored riskier than 25% 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 of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)Ide Analogs in Participants With Chronic Hepatitis B Virus Infection NCT05005507 · started 2021 · scored riskier than 45% of active trials terminated
A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection NCT03982186 · started 2019 · scored riskier than 15% 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.