Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism

Model scores of the 29,894 trials active now.

Model score 16% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 9% of the time (803 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 2024-06-19. 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.

• Sponsor's past termination rate: 17.1% (raises risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Has a data monitoring committee: Yes (raises risk) · Design
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: stagekidneyckdpriorchronic
  Phrases that lowered it: evaluate theto evaluatemgphysicalday
• Phase: 3 (lowers risk) · Design
• Blinding: triple (raises risk) · Design
• Maximum age: 17 (raises risk) · Who can join
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Minimum age: 8 (raises risk) · Who can join
• Design: sequential (lowers risk) · Design
• Disease area, neurology: No (lowers risk) · Disease area
• Sponsor's past trials: 41 (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
• Collaborators: 0 (raises 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.

• Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI NCT03602261 · started 2018 · scored riskier than 45% of active trials terminated
• Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children Aged 10-16 With Chronic Kidney Disease (CKD) NCT01020487 · started 2010 · scored riskier than 23% of active trials completed
• Study of KRN23 (Burosumab), a Recombinant Fully Human Monoclonal Antibody Against Fibroblast Growth Factor 23 (FGF23), in Pediatric Subjects With X-linked Hypophosphatemia (XLH) NCT02163577 · started 2014 · scored riskier than 28% of active trials completed
• Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002 NCT02282813 · started 2013 · scored riskier than 68% of active trials completed
• Trial Of Paricalcitol and Cholecalciferol(Vitamin D3) in the Treatment Of Secondary Hyperparathyroidism in Patients After ROUX-EN-Y Gastric Bypass Surgery NCT01138475 · started 2010 · 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.