Phase 3, Open-label, Single-dose, Study of AAV5-hFIXco-Padua, CSL222, in Japanese Adult Male Subjects with Severe or Moderately Severe Hemophilia B
Phase 3
Recruiting
- Conditions
- Hemophilia B
- Registration Number
- JPRN-jRCT2033230266
- Lead Sponsor
- Akama Hideto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 4
Inclusion Criteria
Males of Japanese origin, Age >= 18 years
Subject with congenital hemophilia B with known severe or moderately severe FIX deficiency (<= 2% of normal circulating FIX) for which the subject is on continuous routine FIX prophylaxis
> 150 previous exposure days of FIX replacement therapy
Exclusion Criteria
History of FIX inhibitors
Positive human immunodeficiency virus serological test
Hepatitis B or C infection
Known coagulation disorder other than hemophilia B
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method