A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Patients with Hemophilia B
Phase 1
- Conditions
- Hemophilia BMedDRA version: 16.1Level: LLTClassification code 10060614Term: Hemophilia B (Factor IX)System Organ Class: 100000004850Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2012-005489-37-ES
- Lead Sponsor
- CSL Behring GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 97
Inclusion Criteria
? Male subjects, up to 65 years old
? Participated in a CSL-sponsored rIX-FP (CSL654) study, including study CSL654_3001 or study CSL654_3002.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
? Unwilling to participate in the study for a total of 100 exposure days.
? Currently receiving a therapy not permitted during the study.
? Any issue that, in the opinion of the investigator, would render the subject unsuitable for participation in 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