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

First listed
Jul 27, 2023
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

Related Studies