A Study to Evaluate Long-term Safety and Clinical Activity of Givosiran (ALN-AS1) in Patient With Acute Intermittent Porphyria (AIP)

Model scores of the 29,894 trials active now.

Model score 24% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 21% of the time (1,462 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 2021-11-05. 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.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: long termterm safetythe longcompletedextension
  Phrases that lowered it: multipleevaluate theto evaluatepharmacokineticsallergies
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 1/2 (raises risk) · Design
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Design: single group (raises risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Has a data monitoring committee: No (lowers risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Disease area, cancer: No (lowers risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Disease area, neurology: No (lowers risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Disease area, dermatology: Yes (raises risk) · Disease area
• Trials the sponsor started in the prior 2 years: 11 (raises risk) · Sponsor's track record
• Sponsor's past trials: 14 (lowers risk) · Sponsor's track record
• Blinding: none (raises risk) · Design
• Number of arms: 1 (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Maximum age: not given (raises risk) · Who can join
• Drug's FAERS reports in the prior 12 months: 0 (raises risk) · Drug's FDA history

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.

• A Phase 1 Study of Givosiran (ALN-AS1) in Patients With Acute Intermittent Porphyria (AIP) NCT02452372 · started 2015 · scored riskier than 16% of active trials completed
• Trial to Evaluate Safety, Tolerability, and Parmacokinetics of ALN-TTR02 in Healthy Volunteer Subjects NCT01559077 · started 2012 · scored riskier than 4% of active trials completed
• ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP) NCT03338816 · started 2017 · scored riskier than 13% of active trials completed
• A Phase 1/2 Study of an Investigational Drug, ALN-CC5, in Healthy Adult Volunteers and Patients With PNH NCT02352493 · started 2015 · scored riskier than 6% of active trials completed
• An Extension Study of an Investigational Drug, Lumasiran (ALN-GO1), in Participants With Primary Hyperoxaluria Type 1 NCT03350451 · started 2018 · scored riskier than 73% 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.