Pharmacokinetics and Safety of rFVIIIFc Manufactured at 15,000 L (15K) Scale (Elevate)
A Randomized, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) Manufactured at 15K Scale and at Different Vial Strengths in Previously Treated Subjects With Severe Hemophilia A
Sponsor: Bioverativ Therapeutics Inc.
Listed as NCT02502149, this PHASE3 trial focuses on Severe Hemophilia A and remains completed. Sponsored by Bioverativ Therapeutics Inc., it has been updated 11 times since 2015, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
11 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
▶ Show 6 earlier versions
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May 2018 — Jun 2018 [monthly]
Completed PHASE3
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Jan 2018 — May 2018 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
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Jul 2017 — Jan 2018 [monthly]
Active Not Recruiting PHASE3
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Mar 2017 — Jul 2017 [monthly]
Active Not Recruiting PHASE3
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Feb 2017 — Mar 2017 [monthly]
Active Not Recruiting PHASE3
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Jan 2017 — Feb 2017 [monthly]
Active Not Recruiting PHASE3
First recorded
Aug 2015
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Bioverativ Therapeutics Inc.
- Swedish Orphan Biovitrum
For direct contact, visit the study record on ClinicalTrials.gov .