deltatrials
Completed PHASE3 INTERVENTIONAL 1-arm NCT02408484

Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin in Paediatric Subjects With Fibrinogen Deficiency

Prospective, Open-label, Uncontrolled, Phase III Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery in Paediatric Subjects With Congenital Fibrinogen Deficiency

Sponsor: Octapharma

Conditions Congenital Fibrinogen Deficiency
Interventions Octafibrin
Updated 13 times since 2017 Last updated: Dec 21, 2020 Started: Dec 31, 2015 Primary completion: Jun 11, 2019 Completion: Jun 11, 2019
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 Congenital Fibrinogen Deficiency and is currently completed. Octapharma leads this study, which shows 13 recorded versions since 2015 — 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 snapshot~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshot~Jun 2018 – ~Dec 2018 · 6 months · monthly snapshot~Dec 2018 – ~Mar 2019 · 3 months · monthly snapshot~Mar 2019 – ~Aug 2019 · 5 months · monthly snapshot~Aug 2019 – ~Nov 2019 · 3 months · monthly snapshot~Nov 2019 – ~Jul 2020 · 8 months · monthly snapshot~Jul 2020 – ~Jan 2021 · 6 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 · 10 months · monthly snapshot

Change History

13 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 8 earlier versions

  1. Jul 2020 — Jan 2021 [monthly]

    Completed PHASE3

  2. Nov 2019 — Jul 2020 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  3. Aug 2019 — Nov 2019 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  4. Mar 2019 — Aug 2019 [monthly]

    Recruiting PHASE3

  5. Dec 2018 — Mar 2019 [monthly]

    Recruiting PHASE3

  6. Jun 2018 — Dec 2018 [monthly]

    Recruiting PHASE3

  7. Feb 2017 — Jun 2018 [monthly]

    Recruiting PHASE3

  8. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Dec 2015

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