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Clinical Trials/2023-503765-37-00
2023-503765-37-00RecruitingPhase 3

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

CSL Behring LLC10 sites in 6 countries28 target enrollmentStarted: March 4, 2024Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Enrollment
28
Locations
10
Primary Endpoint
Number of Participants With Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To assess the long-term safety in adult male subjects with hemophilia B who were treated with CSL222 in Study CSL222_2001 or Study CSL222_3001

Study Design

Allocation
Not Applicable
Primary Purpose
Long-term Follow-up
Masking
None

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Received treatment with CSL222 in Study CSL222_2001 or Study CSL222_3001, and completed participation in Study CSL222_2001 or Study CSL222_3001 or at least 5 years have passed since receiving CSL
  • •Provided written informed consent.
  • •Willing and able to adhere to all protocol requirements.

Exclusion Criteria

  • •There are no exclusion criteria in this study

Outcomes

Primary Outcomes

Number of Participants With Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)

Number of Participants With Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)

Percentage of Participants with SAEs and AESIs

Percentage of Participants with SAEs and AESIs

Number of SAEs and AESIs

Number of SAEs and AESIs

Secondary Outcomes

  • Annualized Bleeding Rate (ABR)
  • Number of Participants With Zero Total, Spontaneous, Joint, and Traumatic Bleeding Episodes
  • Endogenous Factor IX (FIX) Activity
  • Change from Baseline by Visit in Endogenous FIX Activity
  • Annualized Consumption of FIX Replacement Therapy
  • Annualized Infusion Rate of FIX Replacement Therapy
  • Number of Participants Remaining Free of Continuous FIX Prophylaxis
  • Percentage of Participants Remaining Free of Continuous FIX Prophylaxis
  • Number of New Target Joints
  • Percentage Resolution of Pre-existing Target Joints
  • EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Index Value
  • Change From Baseline in EQ-5D-5L Index Value
  • EQ-5D VAS Score
  • Change From Baseline in EQ-5D VAS Score
  • Hemophilia Quality of Life Questionnaire (Hem-A-QoL) Total Score
  • Change From Baseline in Hem-A-QoL Total Score

Investigators

Sponsor Class
Laboratory/Research/Testing facility
Responsible Party
Principal Investigator
Principal Investigator

Trial Registration Coordinator

Scientific

CSL Behring LLC

Study Sites (10)

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