deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT01454739

Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A (ASPIRE)

An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia A

Sponsor: Bioverativ Therapeutics Inc.

Conditions Hemophilia A
Interventions rFVIIIFc
Updated 12 times since 2017 Last updated: Dec 16, 2020 Started: Dec 31, 2011 Primary completion: Oct 31, 2017 Completion: Oct 31, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Hemophilia A and is currently completed. Bioverativ Therapeutics Inc. leads this study, which shows 12 recorded versions since 2011 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotEnrolling By Invitation~Feb 2017 – ~Mar 2017 · 28 days · monthly snapshotEnrolling By Invitation~Mar 2017 – ~Jun 2017 · 3 months · monthly snapshotEnrolling By Invitation~Jun 2017 – ~Oct 2017 · 4 months · monthly snapshotEnrolling By Invitation~Oct 2017 – ~Jan 2018 · 3 months · monthly snapshotActive Not Recruiting~Jan 2018 – ~Jun 2018 · 5 months · monthly snapshotCompleted~Jun 2018 – ~Dec 2018 · 6 months · monthly snapshotCompleted~Dec 2018 – ~Jan 2021 · 25 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 12 months · monthly snapshotCompleted

Change History

12 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. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Dec 2018 — Jan 2021 [monthly]

    Completed PHASE3

Show 7 earlier versions
  1. Jun 2018 — Dec 2018 [monthly]

    Completed PHASE3

  2. Jan 2018 — Jun 2018 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  3. Oct 2017 — Jan 2018 [monthly]

    Active Not Recruiting PHASE3

    Status: Enrolling By InvitationActive Not Recruiting

  4. Jun 2017 — Oct 2017 [monthly]

    Enrolling By Invitation PHASE3

  5. Mar 2017 — Jun 2017 [monthly]

    Enrolling By Invitation PHASE3

  6. Feb 2017 — Mar 2017 [monthly]

    Enrolling By Invitation PHASE3

  7. Jan 2017 — Feb 2017 [monthly]

    Enrolling By Invitation PHASE3

    First recorded

Dec 2011

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Bioverativ Therapeutics Inc.
Data source: Sanofi

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