Long - Term Follow Up of Sickle Cell Disease and Beta-thalassemia Subjects Previously Exposed to BIVV003 or ST-400.
Running, not enrolling
Conditions studied: Blood and Lymphatic Diseases
In brief
Primary Objectives: Long-term safety of BIVV003 in participants with severe sickle cell disease (SCD) and ST- 400 in participants with transfusion-dependent beta-thalassemia (TDT) Secondary Objectives: * Long-term efficacy of the biological treatment effect of BIVV003 in SCD * Long-term efficacy of the clinical treatment effect of BIVV003 on SCD-related clinical events * Long-term efficacy of the biological treatment effect of ST-400 in TDT * Long-term efficacy of the clinical treatment effect of ST-400 in TDT
Key facts
- Study ID
- NCT05145062
- Run by
- Sangamo Therapeutics
- People needed
- 8
- Starts
- 2021-12-21
- Expected to finish
- 2038-07-14
- Last updated by the study team
- 2025-11-12
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Received treatment with BIVV003 or ST-400 in one of the parent studies (ACT16222, ST- 400-01) or any future studies with BIVV003
- Capable of giving signed informed consent (and if applicable assent)
You may not qualify if…
- Unable to comply with study visit schedule or study procedures
- Any other reason that, in the opinion of the Investigator or Medical Monitor, would render the participant unsuitable for participation in the study The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Where it is running
- UCSF Benioff Children's Hospital — Oakland, California, United States
- University of California Davis Health System — Sacramento, California, United States
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States
- Boston Children's Hospital — Boston, Massachusetts, United States
- Karmanos Cancer Institute — Detroit, Michigan, United States
- Henry Ford Health System — Detroit, Michigan, United States
- University of Minnesota — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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