Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency
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|ClinicalTrials.gov Identifier: NCT02065882|
Recruitment Status : Unknown
Verified July 2019 by Biotest.
Recruitment status was: Recruiting
First Posted : February 19, 2014
Last Update Posted : July 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Congenital Afibrinogenemia Congenital Hypofibrinogenemia||Biological: BT524 (fibrinogen concentrate from human plasma)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||November 2020|
Single intravenous infusion of a fixed dose of 70 mg BT524 per kilogram body weight (BW)
Biological: BT524 (fibrinogen concentrate from human plasma)
single intravenous infusion
- Terminal Elimination Half-life (t1/2) for fibrinogen antigen, [ Time Frame: Prior to the initial dose on day 1, at the end of the infusion and 0.5, 1, 2, 4, 8 hours post dose, 24, 48,96, 168, 240h and 336 hours post-dose ]The primary objective of this study is to investigate the 14 day single-dose pharmacokinetics of BT524 following intravenous (IV) infusion in patients with congenital afibrinogenemia or severe congenital hypofibrinogenemia (part I).
- Terminal Elimination Half-life (t1/2) for fibrinogen activity [ Time Frame: Prior to the initial dose on day 1, at the end of the infusion and 0.5, 1, 2, 4, 8 hours post dose, 24, 48,96, 168, 240 and 336 hours post-dose ]Secondary objectives are to investigate the 14 day single-dose pharmacodynamics of BT524, and the surrogate efficacy and safety of BT524 in part I of the study. In addition, the hemostatic efficacy, surrogate efficacy, and safety of single and/or repetitive administrations for on-demand prophylaxis (ODP) and/or on-demand treatment (ODT) of bleeding events will be investigated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065882
|Contact: Claudia Schulte||+49 6103 801 ext email@example.com|
|Contact: Joachim Schütze, PhD||+49 6103 801 ext firstname.lastname@example.org|
|Site 07||Not yet recruiting|
|Principal Investigator:||Claudia Djambas Khayat, MD||Hôtel Dieu de France, Dept. of Pediatrics|