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A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB)

NCT02797522 on ClinicalTrials.gov Phase 1 Arrowhead Pharmaceuticals (industry) Started 2016-06-30 Terminated
Riskier than 5% of active trials
this trial: 5% 0% 36%

Model scores of the 29,894 trials active now.

Model score 5% for any early termination, 0% 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

Terminated on 2016-11-30, after 2016-06-30 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

0% 25% 50% 75% 100% 0123456 yr completed 91% terminated 8%

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2016-11-30. 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

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
11 (typical: 2)
Allocation
randomized
Design
parallel
Primary purpose
treatment
Blinding
quadruple (typical: 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
Yes (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
4 (typical: 1)
Drug has FAERS history
Yes (typical: 64% yes)
Drug's FAERS reports before start
189249 (typical: 2148)
Drug's FAERS reports in the prior 12 months
46507 (typical: 412.5)
Drug's FAERS reports marked serious
74.3% (typical: 85.6%)
Drug's FAERS reports with a death
15.0% (typical: 15.9%)

Disease area and drugs

Disease areas
infectious disease, digestive
Drugs matched to FDA substances
acetaminophen, 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

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.