Clinical Trial

Long - Term Follow Up of Sickle Cell Disease and Beta-thalassemia Subjects Previously Exposed to BIVV003 or ST-400.

Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
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
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2021-11-22; most recent amendment 2025-11-07.
Status change: Enrolling by Invitation → Active, Not Recruiting 2025-11-07
Status change: Recruiting → Enrolling by Invitation 2022-12-14
Status change: Not Yet Recruiting → Recruiting 2021-12-23
Trial Details
NCT Number NCT05145062
Lead Sponsor Sangamo Therapeutics
Conditions Blood and Lymphatic Diseases
Enrollment 8 participants
Start Date 2021-12-21
Primary Completion 2038-07-14 (estimated)
Study Completion 2038-07-14 (estimated)
Updated on ClinicalTrials.gov 2025-11-12