Last updated on January 2017

A Phase III Study on the Safety Pharmacokinetics and Efficacy of Coagulation Factor VIIa


Brief description of study

The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or IX in 12 patients ( birth to <6 years old), and 12 patients (≥6 years old to <12 years old).

Detailed Study Description

A Phase III Study on the Safety, Pharmacokinetics, and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Pediatric Patients from birth to <12 years old with Inhibitors to Factor VIII or IX: PerSept 2

Clinical Study Identifier: NCT02448680

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Michael Wang, MD

University of Colorado Denver Hemophilia & Thrombosis Center
Aurora, CO United States
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Meg Carini, LPN,BS

Jimmy Everest Center for Cancer and Bleeding Disorders
Oklahoma City, OK United States
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Janna Journeycake

UT Southwestern Medical Center at Dallas / Children's Medical Center
Dallas, TX United States
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Meg Carini, LPN,BS

University Multiprofile Hospital for Active Treatment "Sveti Georgi"
Plovdiv, Bulgaria
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Vladimir Komrska, MD

University Hospital Motol
Prague, Czech Republic
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Tamila Nadiradze

Hematology of Department Hemophilia and Thromboses center
Tbilisi, Georgia
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Ismail Haroon Mitha

Worthwhile Clinical Trials
Benoni, South Africa
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Kateryna Vilchevska

National Specialized Children's Hospital OKHMATDYT, Centre for Hemostatic Pathology (Ukraine)
Kyiv, Ukraine
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Oleksandra Stasyshyn

Institute of Blood Pathology and Transfusion Medicine
Lviv, Ukraine
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