First-in-Human and Proof-of-Mechanism Study of ARC19499 Administered to Hemophilia Patients

Model scores of the 29,894 trials active now.

Model score 8% 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 14% of the time (117 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.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2011-12-28. 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.

• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: patients musttypepatientstudy entryuln
  Phrases that lowered it: participantsscreeningmalepharmacokineticspatients who
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 1 (lowers risk) · Design
• Blinding: quadruple (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Has a data monitoring committee: No (lowers risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Number of arms: 4 (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor's past termination rate: 7.4% (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Sponsor's past trials: 27 (lowers risk) · Sponsor's track record
• Disease area, neurology: No (lowers risk) · Disease area
• Trials the sponsor started in the prior 2 years: 10 (lowers risk) · Sponsor's track record
• 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.

• Dose-escalation Study to Investigate the Safety, PK, and PD of ISU304/CB2679d in Hemophilia B Patients NCT03186677 · started 2017 · scored riskier than 10% of active trials completed
• A Study to Investigate the Safety, Tolerability, PK and PD of MG1113 in Healthy Subjects and Hemophilia Patients NCT03855696 · started 2019 · scored riskier than 2% of active trials completed
• Study of the Efficacy and Safety PF-06741086 in Adult and Teenage Participants With Severe Hemophilia A or Moderately Severe to Severe Hemophilia B NCT03938792 · started 2020 · scored riskier than 40% of active trials completed
• A Phase 1 Study of an Investigational Drug, ALN-AT3SC, in Healthy Volunteers and Hemophilia A or B Patients NCT02035605 · started 2014 · scored riskier than 12% of active trials completed
• KN057 Multiple Dose Study in Moderately Severe to Severe Hemophilia NCT05421429 · started 2022 · scored riskier than 13% 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.