deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT02281500

Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia (IG0902)

Multicenter, Prospective, Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Patients With Congenital Afibrinogenemia

Sponsor: Grifols Therapeutics LLC

Conditions Congenital Afibrinogenemia
Interventions Human Plasma-Derived Fibrinogen Concentrate
Updated 17 times since 2017 Last updated: Mar 22, 2022 Started: Jul 22, 2016 Primary completion: Nov 11, 2019 Completion: Nov 11, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Congenital Afibrinogenemia and is currently completed. Grifols Therapeutics LLC leads this study, which shows 17 recorded versions since 2016 — 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 – ~Aug 2017 · 6 months · monthly snapshot~Aug 2017 – ~Feb 2018 · 6 months · monthly snapshot~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Nov 2018 · 4 months · monthly snapshot~Nov 2018 – ~Aug 2019 · 9 months · monthly snapshot~Aug 2019 – ~Apr 2020 · 8 months · monthly snapshot~Apr 2020 – ~Nov 2020 · 7 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Apr 2022 · 15 months · monthly snapshot~Apr 2022 – ~Dec 2022 · 8 months · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Jul 2024 · 18 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

17 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE1/PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  4. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE1_PHASE2

▶ Show 12 earlier versions

  1. Apr 2022 — Dec 2022 [monthly]

    Completed PHASE1_PHASE2

  2. Jan 2021 — Apr 2022 [monthly]

    Completed PHASE1_PHASE2

  3. Nov 2020 — Jan 2021 [monthly]

    Completed PHASE1_PHASE2

  4. Apr 2020 — Nov 2020 [monthly]

    Completed PHASE1_PHASE2

    Status: Recruiting → Completed

  5. Aug 2019 — Apr 2020 [monthly]

    Recruiting PHASE1_PHASE2

  6. Nov 2018 — Aug 2019 [monthly]

    Recruiting PHASE1_PHASE2

  7. Jul 2018 — Nov 2018 [monthly]

    Recruiting PHASE1_PHASE2

  8. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE1_PHASE2

  9. Feb 2018 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

  10. Aug 2017 — Feb 2018 [monthly]

    Recruiting PHASE1_PHASE2

  11. Feb 2017 — Aug 2017 [monthly]

    Recruiting PHASE1_PHASE2

  12. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

Jul 2016

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Grifols Therapeutics LLC
  • Instituto Grifols, S.A.
Data source: Grifols Therapeutics LLC

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

Study Locations