An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A

Model scores of the 29,894 trials active now.

Model score 15% 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 10% of the time (139 trials).

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

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2019-09-23. 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.

• Accepts healthy volunteers: No (raises risk) · Who can join
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: keymay applycriteria mayprotocol definedother protocol
  Phrases that lowered it: bleedingparticipantevaluateefficacysevere
• Phase: 3 (lowers risk) · Design
• Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
• Design: single group (raises risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Minimum age: not given (lowers risk) · Who can join
• Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
• Number of arms: 1 (raises risk) · Design
• Collaborators: 1 (raises risk) · Design
• Disease area, neurology: No (lowers risk) · Disease area
• Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record

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.

• Study to Determine the Safety and Efficacy of rFIXFc in Previously Untreated Males With Severe Hemophilia B NCT02234310 · started 2014 · scored riskier than 22% of active trials completed
• Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Pediatric Subjects With Hemophilia A NCT01458106 · started 2012 · scored riskier than 15% of active trials completed
• Pharmacokinetics of rFVIIIFc at Two Vial Strengths NCT02083965 · started 2014 · scored riskier than 11% of active trials completed
• Study of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in Previously Treated Pediatric Participants With Hemophilia B NCT01440946 · started 2012 · scored riskier than 22% of active trials completed
• Pharmacokinetics and Safety of rFVIIIFc Manufactured at 15,000 L (15K) Scale NCT02502149 · started 2015 · scored riskier than 8% 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.