Long-term Follow-up Study of Male Adults With Hemophilia B Previously Treated With Etranacogene Dezaparvovec (CSL222)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
CSL Behring
Study ID
NCT05962398
Status
Enrolling By Invitation

Conditions

  • Hemophilia B

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AAV5-hFIXco-Padua — GENETIC
    Single intravenous infusion of AAV5-hFIXco-Padua in the study CSL222\_2001 (NCT03489291) or CSL222\_3001 (NCT03569891).

Study Details

The primary purpose of this study is to assess the long-term safety and efficacy in male adults with hemophilia B who were treated with CSL222 (CSL222) in parent studies CSL222\_2001 (NCT03489291) or CSL222\_3001 (NCT03569891).

Key Dates

Start date
Aug 30, 2023
Status verified
Jul 2025
Primary completion
Mar 23, 2035
Completion
Mar 23, 2035

Study Design

Enrollment
56 participants (estimated)

Arms

  • Arm: CSL222
    Participants who received CSL222 and completed either the study CSL222\_2001 (NCT03489291) or CSL222\_3001 (NCT03569891) will be followed up from Year 5 after administration of CSL222 in parent study up to Year 15.

Primary Outcome Measure

Number of Participants With Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) [ Time Frame: From Year 5 after administration of CSL222 in parent study up to Year 15 ]

Locations (15)

FacilityCityStateZIPSite coordinators
10-15 Phoenix Childrens HospitalPhoenixArizona85016-
10-14 Arkansas Children's Hospital - PharmacologyLittle RockArkansas72202-
10-21 Children's Hospital of Los AngelesLos AngelesCalifornia90027-
10-22 Orthopaedic Institute for ChildrenLos AngelesCalifornia90007-
10-63 UC Davis Medical CenterSacramentoCalifornia95817-
10-12 University of California, San Diego (UCSD)San DiegoCalifornia92121-
10-25 University of Colorado DenverAuroraColorado80045-
10-19 University of South FloridaTampaFlorida33612-
10-10 University of Michigan Medical CenterAnn ArborMichigan48109-
10-16 University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
10-18 Oregon Health & Science UniversityPortlandOregon97239-
10-20 Vanderbilt University Medical CenterNashvilleTennessee37232-
10-28 University of Texas Health Science CenterHoustonTexas77030-
10-26 University of UtahSalt Lake CityUtah84108-
10-62 Washington Institute for CoagulationSeattleWashington98104-

Find similar trials in Phoenix, AZ

By research site
10-15 Phoenix Childrens Hospital· Phoenix, AZ10-14 Arkansas Children's Hospital - Pharmacology· Little Rock, AR10-21 Children's Hospital of Los Angeles· Los Angeles, CA10-22 Orthopaedic Institute for Children· Los Angeles, CA10-63 UC Davis Medical Center· Sacramento, CA10-12 University of California, San Diego (UCSD)· San Diego, CA

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