Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia

Model scores of the 29,894 trials active now.

Model score 14% 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 10% of the time (1,463 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 2024-11-27. 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: 15.1% (raises risk) · Sponsor's track record
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: safety tolerabilityplaceboscreeningsyndrometolerability and
  Phrases that lowered it: evaluateopen labelldlhypercholesterolemiaadolescents
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past trials: 1360 (raises risk) · Sponsor's track record
• Phase: 3 (lowers risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
• Design: parallel (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 148 (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Blinding: double (raises risk) · Design
• Maximum age: 17 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
• Disease area, neurology: No (lowers risk) · Disease area

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 Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia NCT04659863 · started 2021 · scored riskier than 31% of active trials completed
• Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders NCT02392559 · started 2016 · scored riskier than 18% of active trials completed
• Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) NCT03397121 · started 2017 · scored riskier than 69% of active trials completed
• Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia) NCT02624869 · started 2016 · scored riskier than 24% of active trials completed
• Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders NCT01624142 · started 2012 · scored riskier than 33% 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.