Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection

NCT02738008 on ClinicalTrials.gov Phase 2 Arrowhead Pharmaceuticals (industry) Started 2016-03-31 Terminated

Riskier than 24% of active trials

Model scores of the 29,894 trials active now.

Model score 12% 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 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 2016-12-31, after 2016-03-31 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 2016-12-31. 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
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Phase: 2 (raises risk) · Design
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: chronicpatientacutepriorpatients
Phrases that lowered it: efficacyscreeningsafetydayecg
Has a data monitoring committee: Yes (raises risk) · Design
Design: single group (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: 15.9% (lowers risk) · Drug's FDA history
Number of arms: 1 (raises 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
Blinding: none (raises risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Trials the sponsor started in the prior 2 years: 7 (raises risk) · Sponsor's track record
Drug's FAERS reports marked serious: 79.6% (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: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 75 (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: 1 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 7 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 8113 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1203 (typical: 412.5)
Drug's FAERS reports marked serious: 79.6% (typical: 85.6%)
Drug's FAERS reports with a death: 15.9%

Disease area and drugs

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

A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection NCT02065336 · started 2014 · scored riskier than 39% of active trials terminated
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection NCT02604199 · started 2015 · scored riskier than 49% of active trials terminated
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection NCT02604212 · started 2015 · scored riskier than 49% of active trials terminated
Study of ARC-520 in Participants With Hepatitis B Virus e Antigen (HBeAg) Positive Chronic Hepatitis B Virus NCT02452528 · started 2015 · scored riskier than 31% of active trials terminated
Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV) NCT02577029 · started 2015 · scored riskier than 21% of active trials terminated

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.