deltatrials
Completed PHASE3 INTERVENTIONAL 1-arm NCT01712438

Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients

Immunogenicity, Efficacy and Safety of Treatment With Human-cl-rhFVIII in Previously Untreated Patients With Severe Hemophilia A

Sponsor: Octapharma

Conditions Severe Hemophilia A
Interventions Human cl rhFVIII
Updated 16 times since 2017 Last updated: Dec 21, 2020 Started: Feb 28, 2013 Primary completion: Dec 14, 2018 Completion: Dec 20, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01712438, this PHASE3 trial focuses on Severe Hemophilia A and remains completed. Sponsored by Octapharma, it has been updated 16 times since 2013, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Dec 2017 · 10 months · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Dec 2018 · 5 months · monthly snapshot~Dec 2018 – ~Apr 2019 · 4 months · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Aug 2019 · 3 months · monthly snapshot~Aug 2019 – ~Nov 2019 · 3 months · monthly snapshot~Nov 2019 – ~May 2020 · 6 months · monthly snapshot~May 2020 – ~Jan 2021 · 8 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Jul 2024 · 41 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. Feb 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jan 2021 — Feb 2021 [monthly]

    Completed PHASE3

▶ Show 11 earlier versions

  1. May 2020 — Jan 2021 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  2. Nov 2019 — May 2020 [monthly]

    Active Not Recruiting PHASE3

  3. Aug 2019 — Nov 2019 [monthly]

    Active Not Recruiting PHASE3

  4. May 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE3

  5. Apr 2019 — May 2019 [monthly]

    Active Not Recruiting PHASE3

  6. Dec 2018 — Apr 2019 [monthly]

    Active Not Recruiting PHASE3

  7. Jul 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE3

  8. Jun 2018 — Jul 2018 [monthly]

    Active Not Recruiting PHASE3

  9. Dec 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

  10. Feb 2017 — Dec 2017 [monthly]

    Active Not Recruiting PHASE3

  11. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Feb 2013

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Octapharma
Data source: Octapharma

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

Study Locations

Barcelona, Spain , Bonn, Germany , Boston, United States , Caen, France , Cambridge, United Kingdom , Chisinau, Moldova , Edmonton, Canada , Frankfurt, Germany , Hamilton, Canada , Kiev, Ukraine and 27 more locations