Live from ClinicalTrials.gov + Open Targets, fetched 2026-11-12 04:53 UTC. Every row links to its source record.
Postmortem · what the sponsor and named sources said, kept apart from what merely happened at the same time
Early Prophylaxis Immunologic Challenge (EPIC) Study
NCT01376700 · Baxalta now part of Shire · PHASE3 · terminated · last registry update 2021-05-24 · Decision brief
No research has been run for this trial yet, so only the registry's own reason and the timeline are shown.
What was said, and by whom
Stated is the sponsor's own words; Reported is a named third party. The category is our label from a fixed list; the quote is the evidence.
| Kind | Quote | Our category | Source |
|---|---|---|---|
| Stated | “It became unlikely to achieve the study objective of 50% reduction over published inhibitor rates. The Data Monitoring Committee supported this decision.” | – | Registry record, Baxalta now part of Shire |
Also happening at the time. Not shown to be a cause.
Registry events on other trials of drugs against F8 within 12 months either side of this trial's last update, live from ClinicalTrials.gov. Nothing here was stated as a reason.
- 2022-02-04Results posted on the registry: Genzyme, a Sanofi Company, fitusiran + factor concentrates (NCT03417245)
- 2021-12-21Results posted on the registry: Genzyme, a Sanofi Company, fitusiran + Bypassing agents (NCT03417102)
- 2021-12-07Phase 3 first posted: Bayer, Damoctocog alfa pegol (Jivi, BAY94-9027) (NCT05147662)
- 2021-12-06Phase 3 first posted: Pfizer, PF-06741086 (NCT05145127)
- 2021-11-30Results posted on the registry: Swedish Orphan Biovitrum, Recombinant coagulation factor (rFVIIIFc) (NCT03103542)
- 2021-11-26Results posted on the registry: Novo Nordisk A/S, Turoctocog alfa pegol + Turoctocog alfa pegol (NCT03528551)
- 2021-11-23Results posted on the registry: Grifols Therapeutics LLC, Alphanate (NCT03095287)
- 2021-11-23Also stopped (terminated): Grifols Therapeutics LLC, Alphanate (NCT03095287)
- 2021-10-27Results posted on the registry: CSL Behring, rVIII-SingleChain (NCT02172950)
- 2021-10-20Results posted on the registry: Baxalta now part of Shire, Antihemophilic Factor (Recombinant), Porcine Sequence (BAX 802) (NCT02895945)
- 2021-10-20Also stopped (terminated): Baxalta now part of Shire, Antihemophilic Factor (Recombinant), Porcine Sequence (BAX 802) (NCT02895945)
- 2021-10-18Phase 3 first posted: Novo Nordisk A/S, turoctocog alfa pegol (N8-GP) (NCT05082116)
- 2021-10-08Results posted on the registry: BioMarin Pharmaceutical, Valoctocogene Roxaparvovec (NCT03392974)
- 2021-08-06Results posted on the registry: Takeda, von Willebrand factor (Recombinant) + Antihemophilic Factor (Recombinant) (NCT02973087)
- 2021-07-08Phase 3 first posted: Octapharma, Wilate (NCT04953884)
- 2021-07-07Results posted on the registry: Bioverativ, a Sanofi company, rFVIIIFc (NCT03093480)
- 2021-05-14Also stopped (terminated): Baxalta now part of Shire, OBI-1 (NCT01434511)
- 2021-05-10Results posted on the registry: Novo Nordisk A/S, Concizumab + Turoctocog alfa (NCT03196297)
- 2021-05-03Results posted on the registry: Pfizer, Moroctocog-alfa (AF-CC) (NCT04396639)
- 2021-04-15Phase 3 first posted: Zhengzhou Gensciences Inc, Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (NCT04845399)
- 2021-02-18Phase 3 first posted: Bioverativ, a Sanofi company, efanesoctocog alfa (BIVV001) (NCT04759131)
- 2020-12-17Also stopped (withdrawn): City of Hope Medical Center, FVIII Concentrates + FVIII/VWF concentrates (NCT01051544)
- 2020-11-25Phase 3 first posted: Bioverativ, a Sanofi company, efanesoctocog alfa (BIVV001) (NCT04644575)
- 2020-11-03Results posted on the registry: Bayer, Recombinant Factor VIII (Kovaltry, BAY81-8973) + Recombinant Factor VIII (Kovaltry, BAY81-8973) (NCT01311648)
- 2020-10-08Phase 3 first posted: Takeda, TAK-672 (NCT04580407)
What is not public
- Internal portfolio and board discussions
- Unpublished trial data and interim analyses
- Terms of any partner or licence decision