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

Sponsored by Vertex Pharmaceuticals Incorporated

About this trial

Last updated 2 years ago

Study ID

CTX001-131

Status

Enrolling by invitation

Type

Observational

Placebo

No

Accepting

18-75 Years
2+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 4 years ago

What is this trial about?

This is a multi-site, observational study to evaluate the long-term safety and efficacy of CTX001 in subjects who received CTX001 in Study CTX001-111 (NCT03655678) or VX21-CTX001-141 (transfusion-dependent β-thalassemia [TDT] studies) or Study CTX001-121 (NCT03745287) or VX21-CTX001-151 (severe sickle cell disease [SCD] studies; NCT05329649).

What are the participation requirements?

Yes

Inclusion Criteria

- Subjects (or his or her legally appointed and authorized representative or guardian) must sign and date informed consent form (ICF) and, where applicable, an assent form

- Subjects must have received CTX001 infusion in a parent study

No

Exclusion Criteria

- There are no exclusion criteria

Locations

Location

Status