Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 1 of 4)

NCT01758432 on ClinicalTrials.gov Phase 2 Portola Pharmaceuticals (industry) Started 2012-12-31 Completed

Riskier than 8% of active trials

Model scores of the 29,894 trials active now.

Model score 7% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (1,304 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.

How it ended

Completed on 2015-09-30, after 2012-12-31 start.

The score above never used this outcome: 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.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2015-09-30. 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.

What moved the score

Accepts healthy volunteers: Yes (lowers risk) · Who can join
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: boneor plannedages ofthe agesmajor
Phrases that lowered it: healthyvolunteersbloodto evaluateevaluate the
Sponsor's past termination rate: 11.1% (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Blinding: quadruple (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 2 (lowers risk) · Sponsor's track record
Phase: 2 (raises risk) · Design
Primary purpose: treatment (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: 16.4% (lowers risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 96.1% (raises risk) · Drug's FDA history
Number of arms: 7 (lowers risk) · Design
Disease area, psychiatry: 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.

The trial

Design

Phase: 2
Number of arms: 7 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: quadruple (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 1

Who can join

Minimum age: 18
Maximum age: 45 (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 9 (typical: 32)
Sponsor's past termination rate: 11.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 2 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 207 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 26 (typical: 412.5)
Drug's FAERS reports marked serious: 96.1% (typical: 85.6%)
Drug's FAERS reports with a death: 16.4% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: apixaban

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 4 of 4) NCT03551743 · started 2012 · scored riskier than 8% of active trials completed
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 2 of 4) NCT03578146 · started 2012 · scored riskier than 8% of active trials completed
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 3 of 4) NCT03551730 · started 2012 · scored riskier than 8% of active trials completed
Single Ascending Dose Study of PRT064445, a Factor Xa (fXa) Inhibitor Antidote NCT03218241 · started 2012 · scored riskier than 14% of active trials completed
A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects NCT02074358 · started 2014 · scored riskier than 2% 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.