Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) ERT Compared With Imiglucerase in Type I Gaucher Disease

Model scores of the 29,894 trials active now.

Model score 10% 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 15% of the time (734 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 2009-05-05. 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
• Sponsor's past termination rate: 3.8% (lowers risk) · Sponsor's track record
• Phase: 3 (lowers risk) · Design
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: the patientdiseasealfapatient hascirrhosis
  Phrases that lowered it: with typereceivedmethodparticipate inagree
• Drug's FAERS reports with a death: 27.6% (raises risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 27 (lowers risk) · Sponsor's track record
• Has a data monitoring committee: No (lowers risk) · Design
• Minimum age: 2 (lowers risk) · Who can join
• Design: parallel (raises risk) · Design
• Blinding: quadruple (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 96.6% (raises risk) · Drug's FDA history
• Maximum age: not given (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Disease area, neurology: Yes (raises risk) · Disease area
• Number of arms: 2 (raises risk) · Design
• Drug's FAERS reports before start: 507 (lowers risk) · Drug's FDA history
• 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.

• An Open-Label Extension Study of GA-GCB ERT in Patients With Type 1 Gaucher Disease NCT00635427 · started 2008 · scored riskier than 40% of active trials completed
• Phase III Study of ISU302 in Patients With Type 1 Gaucher Disease NCT02770625 · started 2011 · scored riskier than 51% of active trials completed
• Efficacy and Safety Study of Velaglucerase Alfa in Children and Adolescents With Type 3 Gaucher Disease NCT01685216 · started 2012 · scored riskier than 84% of active trials completed
• Plant Cell Expressed Recombinant Human Glucocerebrosidase Extension Trial NCT00705939 · started 2008 · scored riskier than 73% of active trials completed
• Study of Velaglucerase Alfa Enzyme Replacement Therapy in Japanese Patients With Gaucher Disease NCT01614574 · started 2012 · scored riskier than 77% 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.