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Clinical trial

An Extension Study Assessing the Long-term Safety and Efficacy of Etranacogene Dezaparvovec (CSL222) Previously Administered to Adult Male Subjects With Hemophilia B

ID
Name
CSL222_3003
Description
The primary purpose of this study is to assess the long-term safety in male adults with hemophilia B who were treated with CSL222 in studies CSL222_2001 (NCT03489291) or CSL222_3001 (NCT03569891).
Trial arms
Trial start
2023-08-30
Estimated PCD
2035-03-01
Trial end
2035-03-01
Treatment
AAV5-hFIXco-Padua
Single intravenous infusion of AAV5-hFIXco-Padua in the study CSL222_2001 (NCT03489291) or CSL222_3001 (NCT03569891).
Arms:
CSL222
Other names:
Etranacogene dezaparvovec
Size
56
Primary endpoint
Number of Participants With Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
From Year 5 after administration of CSL222 in parent study up to Year 15
Percentage of Participants With SAEs and AESIs
From Year 5 after administration of CSL222 in parent study up to Year 15
Number of SAEs and AESIs
From Year 5 after administration of CSL222 in parent study up to Year 15
Eligibility criteria
Inclusion Criteria: * Treatment with CSL222 in Study CSL222_2001 or Study CSL222_3001. * Provided written informed consent. * Willing and able to adhere to all protocol requirements. Exclusion Criteria: -
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 56, 'type': 'ESTIMATED'}}
Updated at
2024-05-01

1 organization

1 product

1 indication

Organization
CSL Behring
Product
AAV5-hFIXco-Padua
Indication
Hemophilia B