Study of the Safety and Tolerability of HPN-100 Compared to Sodium Phenylbutyrate in Children With Urea Cycle Disorders

Model scores of the 29,894 trials active now.

Model score 18% 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 19% of the time (731 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 2011-08-31. 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.

• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 2 (raises risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: subjectassessdose ofextensionliver
  Phrases that lowered it: sequencedisorderssafety20day
• Disease area, neurology: Yes (raises risk) · Disease area
• Design: single group (raises risk) · Design
• Sponsor's past termination rate: 5.8% (lowers risk) · Sponsor's track record
• Drug's FAERS reports with a death: 38.9% (raises risk) · Drug's FDA history
• Sponsor's past trials: 171 (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 70 (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Maximum age: 17 (raises risk) · Who can join
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports marked serious: 94.4% (raises risk) · Drug's FDA history
• Number of arms: 1 (raises risk) · Design
• Disease area, metabolic: Yes (lowers risk) · Disease area
• 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.

• Study of the Safety, Pharmacokinetics and Efficacy of HPN-100, in Pediatric Subjects With Urea Cycle Disorders (UCDs) NCT01347073 · started 2011 · scored riskier than 48% of active trials completed
• Study of the Safety of HPN (Hyperion)-100 for the Long-Term Treatment of Urea Cycle Disorders (Treat UCD) NCT00947297 · started 2009 · scored riskier than 62% of active trials completed
• Efficacy and Safety of HPN-100 for the Treatment of Adults With Urea Cycle Disorders NCT00992459 · started 2009 · scored riskier than 16% of active trials completed
• UNLOCKED: A Phase 2, Open-label Trial With KB195 in Subjects With a Urea Cycle Disorder NCT03933410 · started 2019 · scored riskier than 21% of active trials terminated
• Short-Term Outcome of N-Carbamylglutamate in the Treatment of Acute Hyperammonemia NCT01599286 · started 2012 · scored riskier than 57% 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.