NCT06271512 A Study of Participants with Β-Thalassemia Treated with Betibeglogene Autotemcel
| NCT ID | NCT06271512 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Genetix Biotherapeutics Inc. |
| Condition | Beta-Thalassemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-01-23 |
| Primary Completion | 2043-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2024-01-23 with a primary completion date of 2043-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main aim of this study is to collect real-world longitudinal data on participants with β-thalassemia treated with betibeglogene autotemcel (beti-cel) in the post marketing setting. To assess the long-term safety, including the risk of newly diagnosed malignancies, after treatment with beti-cel and evaluate the long-term effectiveness of treatment with beti-cel.
Eligibility Criteria
Inclusion Criteria: * Participant must be treated with beti-cel in the post marketing setting at a center in the US that participates in the Registry. * Participant must sign an informed consent and/or assent prior to enrollment as required under applicable laws and regulations. * Participant must have signed an informed consent and/or assent permitting data to be shared with Center for International Blood and Marrow Transplant Research (CIBMTR). * Participant must be followed by a hematologist based in the US. Exclusion Criteria: \- There are no exclusion criteria for Registry participation.
Contact & Investigator
Himal Lal Thakar, MD
STUDY DIRECTOR
bluebird bio, Inc.
Frequently Asked Questions
Who can join the NCT06271512 clinical trial?
This trial is open to participants of all sexes, studying Beta-Thalassemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06271512 currently recruiting?
Yes, NCT06271512 is actively recruiting participants. Contact the research team at clinicaltrials@bluebirdbio.com for enrollment information.
Where is the NCT06271512 trial being conducted?
This trial is being conducted at Oakland, United States, Palo Alto, United States, Minneapolis, United States, New Hyde Park, United States and 2 additional locations.
Who is sponsoring the NCT06271512 clinical trial?
NCT06271512 is sponsored by Genetix Biotherapeutics Inc.. The principal investigator is Himal Lal Thakar, MD at bluebird bio, Inc.. The trial plans to enroll 150 participants.