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ENROLLING BY INVITATION
NCT04208529
PHASE3

A Long-term Follow-up Study in Participants Who Received CTX001

Sponsor: Vertex Pharmaceuticals Incorporated

View on ClinicalTrials.gov

Summary

This is a multi-site, open- label rollover study to evaluate the long-term safety and efficacy of CTX001 in pediatric and adult participants who received CTX001 in parent studies 111 (NCT03655678) 141 (NCT05356195) or 161 (NCT05477563) (transfusion-dependent β-thalassemia \[TDT\] studies) or Study 121 (NCT03745287) or 151 (NCT05329649) or 161(NCT05477563) (severe sickle cell disease \[SCD\] studies).

Official title: A Long-term Follow-up Study of Subjects With β-thalassemia or Sickle Cell Disease Treated With Autologous CRISPR-Cas9 Modified Hematopoietic Stem Cells (CTX001)

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2021-01-20

Completion Date

2039-09-30

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

BIOLOGICAL

CTX001

CTX001 infusion.

Locations (20)

Lucile Packard Children's Hospital

Palo Alto, California, United States

Ann & Robert H. Lurie Children's Hospital of Chicago - Hematology

Chicago, Illinois, United States

Herbert Irving Pavilion - Hematology

New York, New York, United States

New York Presbyterian Hospital - Morgan Stanley Children's Hospital

New York, New York, United States

Levine Children's Hospital - Hematology

Charlotte, North Carolina, United States

The Children's Hospital of Philadelphia - Hematology

Philadelphia, Pennsylvania, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

TriStar Medical Group Children's Specialists - Pediatric Oncology

Nashville, Tennessee, United States

Methodist Healthcare System of San Antonio, Methodist Hospital, Methodist Children's Hospital

San Antonio, Texas, United States

Hopital Universitaire des Enfants Reine Fabiola (HUDERF) - Hematology

Brussels, Belgium

Hospital for Sick Children - Hematology

Toronto, Canada

Toronto General Hospital - Hematology

Toronto, Canada

St. Paul's Hospital - Hematology

Vancouver, Canada

University Hospital Duesseldorf - Department of Pediatric Oncology, Hematology and Clinical Immunology

Düsseldorf, Germany

Center for Pediatric Clinical Studies (CPCS)

Klinik Für Kinder- Und Jugendmedizin, Germany

Regensburg University Hospital, Clinic and Polyclinic for Paediatric and Adolescent Medicine

Regensburg, Germany

IRCSS Ospedale Pediatrico Bambino Gesu - Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica

Rome, Italy

Great Ormond Street Hospital for Children

London, United Kingdom

Hammersmith Hospital - Haematology Dept

London, United Kingdom

University College London Hospital NHS Foundation - Main

London, United Kingdom