A Long-Term Follow-Up Study of Participants With Sickle Cell Disease or Transfusion Dependent β-Thalassemia Who Received EDIT-301

Part of paid clinical trials in Oakland, California.

Sponsor
Editas Medicine, Inc.
Study ID
NCT06363760
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Safety and efficacy assessments — OTHER
    Assessed throughout the duration of the study.

Study Details

The purpose of this study is to evaluate the long-term safety and efficacy of EDIT-301 in participants with severe sickle cell disease (SCD) or transfusion-dependent β-thalassemia (TDT) who have received EDIT-301.

Key Dates

First listed
Apr 12, 2024
Start date
Jun 17, 2024
Status verified
Mar 2025
Primary completion
Aug 31, 2040
Completion
Aug 31, 2040

Study Design

Enrollment
54 participants (estimated)

Arms

  • Arm: All participants
    All participants who complete or discontinue one of the parent studies (EM-SCD-301-001 or EDIT-301-BThal-001)

Primary Outcome Measure

Adverse events of special interest (AESI) [ Time Frame: up to 15 years post EDIT-301 infusion ]

Locations (16)

FacilityCityStateZIPSite coordinators
UCSF Benioff Children's HospitalOaklandCalifornia94609-
Children's Hospital ColoradoAuroraColorado80045-
Smilow Cancer HospitalNew HavenConnecticut06511-
Johns Hopkins All Children's HospitalSt. PetersburgFlorida33701-
Children's Healthcare of AtlantaAtlantaGeorgia30322-
University of MinnesotaMinneapolisMinnesota55410-
Columbia University Medical CenterNew YorkNew York10032-
Columbia University Medical Center - Department of PediatricsNew YorkNew York10032-
Atrium HealthCharlotteNorth Carolina28204-
Cleveland ClinicClevelandOhio44195-
Nationwide Children's HospitalColumbusOhio43205-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Tristar Medical Group Children's Specialists/Sarah Cannon Center for Blood CancersNashvilleTennessee37203-
Texas Oncology - Baylor Charles A. Sammons Cancer CenterDallasTexas75246-
Cook Children'sFort WorthTexas76104-

Find similar trials in Oakland, CA

By condition
Sickle cell disease
By research site
UCSF Benioff Children's Hospital· Oakland, CAChildren's Hospital Colorado· Aurora, COSmilow Cancer Hospital· New Haven, CTJohns Hopkins All Children's Hospital· St. Petersburg, FLChildren's Healthcare of Atlanta· Atlanta, GAUniversity of Minnesota· Minneapolis, MN

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