Dose Confirmation Trial of AAV5-hFIXco-Padua
Launched by CSL BEHRING · Apr 3, 2018
Trial Information
Current as of August 14, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • 1. Male
- • 2. Age ≥18 years
- • 3. Subjects with congenital hemophilia B classified as severe or moderately severe
- • 4. \>20 previous exposure days of treatment with FIX protein
- Exclusion Criteria:
- • 1. History of FIX inhibitors
- • 2. Positive FIX inhibitor test at screening
- 3. Select screening laboratory values \> 2 times upper normal limit:
- • 4. Positive human immunodeficiency virus (HIV) at screening, not controlled with anti-viral therapy
- • 5. Active infection with Hepatitis B or C virus at screening
- • 6. History of Hepatitis B or C exposure, currently controlled by antiviral therapy
About Csl Behring
CSL Behring is a global biotechnology leader focused on developing innovative therapies for patients with serious and rare diseases. As a subsidiary of CSL Limited, the company specializes in the research, development, and manufacture of life-saving biotherapies derived from human plasma. With a strong commitment to scientific excellence and patient care, CSL Behring conducts rigorous clinical trials to advance its portfolio of immunoglobulins, clotting factors, and other biopharmaceuticals. The organization aims to enhance the quality of life for patients worldwide while maintaining the highest standards of safety and efficacy in its products.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ann Arbor, Michigan, United States
Sacramento, California, United States
Phoenix, Arizona, United States
Los Angeles, California, United States
San Diego, California, United States
Patients applied
Trial Officials
Steven Pipe, MD
Principal Investigator
University of Michigan
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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