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All Participants for Beta Thalassemia

N/A
Recruiting
Research Sponsored by bluebird bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 15 years post-beti-cel infusion
Awards & highlights

Study 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.

Eligible Conditions
  • Beta Thalassemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 15 years post-beti-cel infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 15 years post-beti-cel infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants who Experience Each Individual Adverse Events of Interest (AEIs)
Secondary outcome measures
Event-Free Survival
Number of Participants with Serious Adverse Events (SAEs)
Number of Participants with beti-cel related AEs
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: All ParticipantsExperimental Treatment1 Intervention
Participants with β-thalassemia treated with beti-cel in the post-marketing setting will be followed in this registry study for up to 15 years after infusion with beti-cel to collect real-world longitudinal data.

Find a Location

Who is running the clinical trial?

bluebird bioLead Sponsor
20 Previous Clinical Trials
1,893 Total Patients Enrolled
Center for International Blood and Marrow Transplant ResearchNETWORK
38 Previous Clinical Trials
200,193,280 Total Patients Enrolled
Himal Lal Thakar, MDStudy Directorbluebird bio, Inc.
4 Previous Clinical Trials
243 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of Participants With β-Thalassemia Treated With Betibeglogene Autotemcel
2024. "A Study of Participants With β-Thalassemia Treated With Betibeglogene Autotemcel". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06271512.
All > Sacramento
~100 spots leftby Dec 2043
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