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Enrolling by invitation Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT04208529

Public ClinicalTrials.gov record NCT04208529. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 5:56 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT04208529
Recruitment status
Enrolling by invitation
Study type
Interventional
Phase
Phase 3
Enrollment
160 participants

Conditions and interventions

Eligibility (public fields only)

Age range
2 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 19, 2021
Primary completion
Sep 29, 2039
Completion
Sep 29, 2039
Last update posted
Aug 10, 2026

2021 – 2039

United States locations

U.S. sites
9
U.S. states
7
U.S. cities
8
Facility City State ZIP Site status
Lucile Packard Children's Hospital Palo Alto California 94304
Ann & Robert H. Lurie Children's Hospital of Chicago - Hematology Chicago Illinois 60611
Herbert Irving Pavilion - Hematology New York New York 10032
New York Presbyterian Hospital - Morgan Stanley Children's Hospital New York New York 10032
Levine Children's Hospital - Hematology Charlotte North Carolina 28203
The Children's Hospital of Philadelphia - Hematology Philadelphia Pennsylvania 19104
St. Jude Children's Research Hospital Memphis Tennessee 38105
TriStar Medical Group Children's Specialists - Pediatric Oncology Nashville Tennessee 37203
Methodist Healthcare System of San Antonio, Methodist Hospital, Methodist Children's Hospital San Antonio Texas 78229

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04208529, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 10, 2026 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04208529 live on ClinicalTrials.gov.

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