Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection

NCT01368497 on ClinicalTrials.gov Phase 3 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (government) Started 2012-09-30 Completed

Riskier than 22% of active trials

Model scores of the 29,894 trials active now.

Model score 12% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (59 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

Completed on 2016-12-23, after 2012-09-30 start.

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 2016-12-23. 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
Design: single group (raises risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Drug's FAERS reports with a death: 8.7% (lowers risk) · Drug's FDA history
Sponsor's past trials: 224 (lowers risk) · Sponsor's track record
Phase: 3 (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports marked serious: 76.8% (lowers risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Maximum age: 18 (raises risk) · Who can join
Minimum age: 3 (lowers risk) · Who can join
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: chronicscreeningrandomizationto determinebaseline visit
Phrases that lowered it: participantparticipantscountweeksefficacy
Sponsor type: government (raises risk) · Sponsor's track record
Drug's FAERS reports in the prior 12 months: 7057 (lowers risk) · Drug's FDA history
Disease area, neurology: No (lowers risk) · Disease area
Collaborators: 0 (raises risk) · Design
Number of arms: 1 (raises risk) · Design
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: 3 (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: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 2 (typical: 1)

Who can join

Minimum age: 3 (typical: 18)
Maximum age: 18 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: government (typical: academic or other)
Sponsor's past trials: 224 (typical: 32)
Sponsor's past termination rate: 4.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 14 (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: 14937 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 7057 (typical: 412.5)
Drug's FAERS reports marked serious: 76.8% (typical: 85.6%)
Drug's FAERS reports with a death: 8.7% (typical: 15.9%)

Disease area and drugs

Disease areas: infectious disease, digestive
Drugs matched to FDA substances: entecavir, peginterferon alfa2a

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

Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B NCT01369199 · started 2012 · scored riskier than 35% of active trials terminated
A Study of Pegylated Interferon Alfa-2A in Combination With Lamivudine or Entecavir Compared With Untreated Control Group in Children With Hepatitis B Envelope Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB) in the Immune-Tolerant Phase NCT02263079 · started 2014 · scored riskier than 19% of active trials completed
A Study on the Safety, Efficacy and Immune Response Following Sequential Treatment With an Anti-sense Oligonucleotide Against Chronic Hepatitis B (CHB) and Chronic Hepatitis B Targeted Immunotherapy (CHB-TI) in CHB Patients Receiving Nucleos(t)Ide Analogue (NA) Therapy NCT05276297 · started 2022 · scored riskier than 10% of active trials completed
A Clinical Study of 162 in Subjects With Chronic Hepatitis B Virus Infection NCT06159062 · started 2024 · scored riskier than 47% of active trials terminated
Efficacy of VTP-300 in Chronic Hepatitis B Infection NCT05343481 · started 2022 · scored riskier than 17% 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.