Safety and Efficacy of PRX-102 in Patients With Fabry Disease Currently Treated With REPLAGAL® (Agalsidase Alfa)

Model scores of the 29,894 trials active now.

Model score 19% for any early termination, 4% 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 (493 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 2020-01-09. 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) (raises risk) · Wording Phrases that raised it: screeningacutekginjurypain
  Phrases that lowered it: patientsiitherapyefficacycreatinine
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Phase: 3 (lowers risk) · Design
• Design: single group (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Disease area, neurology: Yes (raises risk) · Disease area
• Disease area, cancer: No (lowers risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Number of arms: 1 (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Collaborators: 1 (raises risk) · Design
• Disease area, cardiovascular: Yes (raises risk) · Disease area
• Sponsor's past trials: 7 (raises 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.

• Safety, Efficacy, & PK of PRX-102 in Patients With Fabry Disease Administered Intravenously Every 4 Weeks NCT03180840 · started 2017 · scored riskier than 42% of active trials completed
• Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function NCT02795676 · started 2016 · scored riskier than 47% of active trials completed
• A Multicenter Open-Label Treatment Protocol to Observe the Safety of Replagal (Agalsidase Alfa) Enzyme Replacement Therapy in Canadian Patients With Fabry Disease NCT01298141 · started 2011 · scored riskier than 90% of active trials completed
• Dose-ranging Study of PRX-102 in Adult Fabry Disease Patients NCT01678898 · started 2012 · scored riskier than 48% of active trials completed
• Switch Over Study of Biosimilar Agalsidase Beta for Fabry Disease NCT05843916 · started 2022 · scored riskier than 26% 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.