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

NCT02065882 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-07-03

Study results available
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Summary

This was a prospective, open-label, multicenter, phase I/III study investigating the 14-day single-dose pharmacokinetic and pharmacodynamic properties, efficacy and safety of BT524 following intravenous administration in the treatment or prophylaxis of bleeding in patients with congenital afibrinogenemia or severe congenital hypofibrinogenemia.

Conditions

  • Congenital Afibrinogenemia
  • Congenital Hypofibrinogenemia

Interventions

DRUG

BT524 (Part I)

Single intravenous infusion of 70 mg BT524 per kg body weight.

DRUG

BT524 (Part II)

Single or repetitive intravenous infusion(s) of BT524, depending on the severity of the disorder, location and extent of the bleeding and patient's clinical condition. Dosage based on individual body weight and fibrinogen level.

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • Phoenix Clinical Research

    collaborator OTHER

  • Accovion GmbH

    collaborator INDUSTRY

  • Biotest

    lead INDUSTRY

Principal Investigators

  • Claudia Djambas Khayat, MD · Hôtel Dieu de France, Dept. of Pediatrics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2020-05-18
Completion
2020-11-18

Countries

  • Bulgaria
  • Egypt
  • Germany
  • Lebanon
  • Tunisia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02065882 on ClinicalTrials.gov