A study of the safety and effectiveness of a new treatment from human blood source that replaces the missing clotting factor VIII, including determination of drug level in hemophilia A patients.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 115

Inclusion Criteria

- Diagnosis of severe hemophilia A defined as <1% FVIII:C documented in medical records. - Males between 18 and 65 years of age (Parts 1 and 2). - Males between 12 and 65 years of age (Part 3). - Subjects who have received or are currently receiving FVIII products (plasma-derived and/or recombinant FVIII) and have had >150 exposure days (EDs) with a FVIII product - Written informed consent for study participation obtained before undergoing any study specific procedures.
Are the trial subjects under 18? yes
Number of subjects for this age range: 4
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 109
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

- Any history of or current FVIII inhibitors - Any first order family history of FVIII inhibitors - Use of an Investigational Medicinal Product within 30 days prior to the first rFVIII administration. - Administration of any cryoprecipitate, whole blood or plasma within 30 days prior to screening and 4 days prior to administration of rFVIII or reference product. - Known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII product or hamster protein. - Any known congenital or acquired coagulation disorder other than congenital FVIII deficiency. - Platelet count < 100,000/µL at screening. - HIV positive subjects with a CD4 count < 200/mm3, in their medical history or at screening if available results are older than one year. (HIV positive subjects may participate in the study and antiviral therapy are permitted, at the discretion of the Investigator). - Subject currently receiving IV immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment. - Subject with serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) values > 5 times (x) the upper limit of normal (ULN) at Screening. - Subjects with serum creatinine values > 2 x ULN at Screening. - Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction and arterial embolus within 3 months prior to Day 1. - Experienced life-threatening bleeding episode or had major surgery or an orthopedic surgical procedure during the 3 months prior to Day 1. - Demonstrated inability (e.g., language problem or mental condition) or unwillingness to comply with study procedures or history of noncompliance. - Employee at the study site, or spouse/partner or relative of the investigator or subinvestigators. - Re-entry of subjects previously enrolled or participating in the current study. - Suspected inability (eg, language problems) or unwillingness to comply with study procedures. - Mental condition rendering the subject (or the subject's legally acceptable representative[s]) unable to understand the nature, scope and possible consequences of the study). - Any condition that is likely to interfere with evaluation of the IMP or satisfactory conduct of the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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