deltatrials
Completed PHASE3 INTERVENTIONAL 1-arm NCT02065882

Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency

A Prospective, Open-label, Phase I/III Study Investigating Pharmacokinetic Properties of BT524 and Efficacy and Safety of BT524 in the Treatment and Prophylaxis of Bleeding in Patients With Congenital Fibrinogen Deficiency

Sponsor: Accovion GmbH

Conditions Congenital Afibrinogenemia Congenital Hypofibrinogenemia
Interventions BT524 (Part I) BT524 (Part II)
Updated 10 times since 2017 Last updated: Jun 17, 2025 Started: Mar 31, 2013 Primary completion: May 18, 2020 Completion: Nov 18, 2020
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 Congenital Afibrinogenemia and Congenital Hypofibrinogenemia, this trial is completed. The trial is conducted by Accovion GmbH and has accumulated 10 data snapshots since 2013. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Feb 2018 · 13 months · monthly snapshotRecruiting~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshotRecruiting~Jun 2018 – ~Aug 2019 · 14 months · monthly snapshotRecruiting~Aug 2019 – ~Jan 2021 · 17 months · monthly snapshotRecruiting~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshotRecruiting~Oct 2021 – ~Sep 2022 · 11 months · monthly snapshotUnknown Status~Sep 2022 – ~Jul 2024 · 22 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Aug 2025 · 11 months · monthly snapshotCompleted~Aug 2025 – present · 11 months · monthly snapshotCompleted

Change History

10 versions recorded

  1. Aug 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Aug 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Sep 2022 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Unknown Status → Completed

  5. Oct 2021 — Sep 2022 [monthly]

    Unknown Status PHASE3

    Status: Recruiting → Unknown Status

▶ Show 5 earlier versions

  1. Jan 2021 — Oct 2021 [monthly]

    Recruiting PHASE3

  2. Aug 2019 — Jan 2021 [monthly]

    Recruiting PHASE3

  3. Jun 2018 — Aug 2019 [monthly]

    Recruiting PHASE3

  4. Feb 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

    Phase: PHASE2_PHASE3 → PHASE3

  5. Jan 2017 — Feb 2018 [monthly]

    Recruiting PHASE2_PHASE3

    First recorded

Mar 2013

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Accovion GmbH
  • Biotest
  • ICON plc
  • Phoenix Clinical Research
Data source: Biotest

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

Study Locations