Androgen Reduction in Congenital Adrenal Hyperplasia, Phase 1

NCT02574910 on ClinicalTrials.gov Phase 1 University of Texas Southwestern Medical Center (academic or other) Started 2017-08-01 Terminated

Riskier than 54% of active trials

Model scores of the 29,894 trials active now.

Model score 17% for any early termination, 9% 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 (137 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2023-06-03, after 2017-08-01 start.

Reason given by the sponsor: “enrollment”

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 2023-06-03. 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: ulntherapyperformanceuncontrolledpatients
Phrases that lowered it: genotypeinclusiveasthmasubjectkg
Sponsor's past termination rate: 15.8% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1 (lowers risk) · Design
Collaborators: 3 (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 67 (lowers risk) · Sponsor's track record
Has a data monitoring committee: Yes (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 2 (lowers risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports marked serious: 74.9% (lowers risk) · Drug's FDA history
Sponsor's past trials: 209 (lowers risk) · Sponsor's track record
Number of arms: 3 (lowers risk) · Design
Responsible party: principal investigator (lowers risk) · Design
Maximum age: 9 (raises risk) · Who can join
Drug's FAERS reports with a death: 20.2% (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: 1 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: sequential (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 3 (typical: 0)
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 2 (typical: 18)
Maximum age: 9 (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 209 (typical: 32)
Sponsor's past termination rate: 15.8% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 67 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 10007 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2674 (typical: 412.5)
Drug's FAERS reports marked serious: 74.9% (typical: 85.6%)
Drug's FAERS reports with a death: 20.2% (typical: 15.9%)

Disease area and drugs

Disease areas: metabolic, urogenital, endocrine
Drugs matched to FDA substances: abiraterone

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 Ph2b to Evaluate Clinical Efficacy and Safety of Tildacerfont in Adult CAH NCT04457336 · started 2020 · scored riskier than 26% of active trials terminated
A Ph2b to Evaluate Tildacerfont in the Reduction of Glucocorticoid Steroid Doses in Adult CAH NCT04544410 · started 2021 · scored riskier than 21% of active trials terminated
Conventional Androgen Deprivation Therapy (ADT) With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and ADT NCT03777982 · started 2020 · scored riskier than 60% of active trials terminated
Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adolescent Males With Hypogonadotropic Hypogonadism (HH) (MK-8962-043) NCT03019575 · started 2017 · scored riskier than 16% of active trials completed
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 (Crinecerfont) in Pediatric Participants With Congenital Adrenal Hyperplasia NCT04045145 · started 2019 · 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.