deltatrials
Completed PHASE3 INTERVENTIONAL 1-arm NCT02234323

An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A

An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia A

Sponsor: Bioverativ, a Sanofi company

Conditions Hemophilia A
Interventions rFVIIIFc
Updated 16 times since 2017 Last updated: Mar 15, 2022 Started: Jan 12, 2015 Primary completion: Sep 23, 2019 Completion: Sep 23, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Hemophilia A, this trial is completed. The trial is conducted by Bioverativ, a Sanofi company and has accumulated 16 data snapshots since 2015. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Mar 2017 · 28 days · monthly snapshot~Mar 2017 – ~Jul 2017 · 4 months · monthly snapshot~Jul 2017 – ~Oct 2017 · 3 months · monthly snapshot~Oct 2017 – ~Mar 2018 · 5 months · monthly snapshot~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshot~Nov 2018 – ~Aug 2019 · 9 months · monthly snapshot~Aug 2019 – ~Nov 2019 · 3 months · monthly snapshot~Nov 2019 – ~Sep 2020 · 10 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~May 2022 · 16 months · monthly snapshot~May 2022 – ~Jul 2024 · 26 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

16 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. May 2022 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jan 2021 — May 2022 [monthly]

    Completed PHASE3

▶ Show 11 earlier versions

  1. Sep 2020 — Jan 2021 [monthly]

    Completed PHASE3

  2. Nov 2019 — Sep 2020 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  3. Aug 2019 — Nov 2019 [monthly]

    Active Not Recruiting PHASE3

  4. Nov 2018 — Aug 2019 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  5. Jun 2018 — Nov 2018 [monthly]

    Recruiting PHASE3

  6. Mar 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

  7. Oct 2017 — Mar 2018 [monthly]

    Recruiting PHASE3

  8. Jul 2017 — Oct 2017 [monthly]

    Recruiting PHASE3

  9. Mar 2017 — Jul 2017 [monthly]

    Recruiting PHASE3

  10. Feb 2017 — Mar 2017 [monthly]

    Recruiting PHASE3

  11. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Jan 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Bioverativ, a Sanofi company
  • Swedish Orphan Biovitrum
Data source: Sanofi

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Auckland, New Zealand , Barcelona, Spain , Bari, Italy , Basingstoke, United Kingdom , Berlin, Germany , Bonn, Germany , Brewer, United States , Brisbane, Australia , Buffalo, United States , Caen, France and 59 more locations