A Phase IIIb Study to Compare Entecavir Plus Tenofovir vs. Adefovir Added to Continuing Lamivudine Therapy in Adult Patients With Lamivudine-Resistant Hepatitis B Infection

NCT00605384 on ClinicalTrials.gov Phase 3 Bristol-Myers Squibb (industry) Started 2008-08-31 Terminated

Riskier than 44% 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 6% of the time (876 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

How it ended

Terminated on 2009-02-28, after 2008-08-31 start.

Reason given by the sponsor: “business”

The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

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 2009-02-28. 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: hepatitistherapychronicevidence ofpurpose
Phrases that lowered it: safety ofand safetyefficacy andtenofovirlamivudine
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 6% (lowers risk) · Sponsor's track record
Responsible party: not given (raises risk) · Design
Phase: 3 (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 113 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 15.5% (lowers risk) · Drug's FDA history
Design: parallel (raises risk) · Design
Primary purpose: treatment (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Has a data monitoring committee: No (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Sponsor's past trials: 150 (lowers risk) · Sponsor's track record
Maximum age: not given (raises risk) · Who can join
Drug's FAERS reports marked serious: 94.1% (raises risk) · Drug's FDA history
Number of arms: 2 (raises 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: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: not given (typical: 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: 150 (typical: 32)
Sponsor's past termination rate: 6% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 113 (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: 7265 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1589 (typical: 412.5)
Drug's FAERS reports marked serious: 94.1% (typical: 85.6%)
Drug's FAERS reports with a death: 15.5% (typical: 15.9%)

Disease area and drugs

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

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 Study of Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Who Failed Previous Treatment NCT01063036 · started 2010 · scored riskier than 39% of active trials completed
Tenofovir Disoproxil Fumarate (Tenofovir DF) Versus Emtricitabine/Tenofovir DF in Subjects Resistant to Lamivudine NCT00737568 · started 2008 · scored riskier than 33% of active trials completed
Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus NCT00410202 · started 2008 · scored riskier than 17% of active trials completed
Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Positive Hepatitis B (China) NCT02836249 · started 2015 · scored riskier than 15% of active trials completed
Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B (China) NCT02836236 · started 2015 · scored riskier than 14% 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.