NCT06271512Recruiting
A Study of Participants with Β-Thalassemia Treated with Betibeglogene Autotemcel
A Safety and Effectiveness Registry Study of Patients with Β-Thalassemia Treated with Betibeglogene Autotemcel (the Glostar Registry)
Source: ClinicalTrials.gov · Last updated 11 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 14 Feb 2024
- Start date
- 23 Jan 2024
- Primary completion date
- Dec 2043
- Lead sponsor
- Genetix Biotherapeutics Inc.
- Diseases
- Thalassaemia
- NCT number
- NCT06271512
What you commit to
- Study type: Observational
- Planned participants: 150
- From 23 Jan 2024 to the primary completion date, Dec 2043
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- \- There are no exclusion criteria for Registry participation.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Texas Children's Hospital Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Cohen Children's Medical Center Coordinator of this site? Confirm its status | New Hyde Park | United States | Recruiting |
| UCSF Benioff Children's Hospitals Coordinator of this site? Confirm its status | Oakland | United States | Recruiting |
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.