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Hemophilia A

Study of a pd vWF/FVIII, Biostate®, in Subjects With Haemophilia A
NCT00879541 | PHASE 2 | INTERVENTIONAL

The aim of this study are to * assess the efficacy of Biostate® \[Study Product (SP)\] in subjects with Haemophilia A * compare the pharmacokinetics of Biostate® \[SP\] with the previously marketed product Biostate® (here referred to as Biostate® \[Reference Product (RP)\]). This study is divided into 3 parts: Part 1: Cross-over pharmacokinetic (PK) component. PK subjects will be randomised to determine the order in which they receive the two study products. This part of the study is double-blinded. Part 2: Efficacy component. All subjects will receive Biostate® \[SP\] as required to manage their haemophilia condition for an estimated period of 6 months (or minimum of 50 exposure days) to assess efficacy and safety of the product. This part of the study is open-label. Part 3: Repeat pharmacokinetic assessment. Subjects who participated in Part 1 (PK component) will undergo a repeat PK assessment on Day 180 following administration of Biostate® \[SP\].

Trial Information
14 Sites
81 Participants
Recruiting
12 Years to 64 Years

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Study Site
Plovdiv,Bulgaria
Study Site
Sofia,Bulgaria
Study Site
Varna,Bulgaria
Study Site
Skopje,Macedonia, The Former Yugoslav Republic of
Study Site
Bialystok,Poland
Study Site
Gdansk,Poland
Study Site
Krakow,Poland
Study Site
Lublin,Poland
Study Site
Poznan,Poland
Study Site
Warszawa,Poland
Study Site
Wroclaw,Poland
Study Site
Barnaul,Russian Federation
Study Site
Kirov,Russian Federation
Study Site
Moscow,Russian Federation

Study Eligibility Criteria

Additional Studies

Additional studies can be found at ClinicalTrials.gov