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NCT05145062 · ClinicalTrials.gov registry record
Long - Term Follow Up of Sickle Cell Disease and Beta-thalassemia Subjects Previously Exposed to BIVV003 or ST-400.
A clinical trial of Blood and Lymphatic Diseases, sponsored by Sangamo Therapeutics.
- Active
- Registry status
- 8
- Enrollment target
- 7
- Study locations
NCT05145062: Active study of Blood and Lymphatic Diseases, sponsored by Sangamo Therapeutics.
NCT05145062 is a study of Blood and Lymphatic Diseases that is active but no longer recruiting, run by Sangamo Therapeutics. The registered enrollment target is 8 participants. The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05145062, a study of Blood and Lymphatic Diseases, is active but no longer recruiting, sponsored by Sangamo Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- 8 participants
- Enrollment target
- 7
- Study locations
Study 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
Primary Outcome
Number of participants with serious adverse events and adverse events related to BIVV003 or ST-400, including new malignancy, new incidence or exacerbation of neurologic or rheumatologic or autoimmune or hematologic disorder, or new incidence of infection potentially related to BIVV003 or ST-400
Conditions Studied
Interventions
- DRUG BIVV003
- DRUG ST-400
Study Locations (7)
California
- UCSF Benioff Children's Hospital - Oakland
- University of California Davis Health System - Sacramento
Michigan
- Karmanos Cancer Institute - Detroit
- Henry Ford Health System - Detroit
Georgia
- Children's Healthcare of Atlanta - Atlanta
Massachusetts
- Boston Children's Hospital - Boston
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-12-21 |
| Est. Completion | 2038-07-14 |
What the registry record for NCT05145062 still lists
NCT05145062 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 8 participants, a relatively small participant target.
The record links to 1 condition, with Blood and Lymphatic Diseases appearing as the primary indexed condition, and to 2 interventions - of which BIVV003 is the first listed.
NCT05145062 lists 7 locations in 5 states (California, Michigan, Georgia).
Frequently Asked Questions
What is clinical trial NCT05145062 about?
NCT05145062 is a clinical study titled "Long - Term Follow Up of Sickle Cell Disease and Beta-thalassemia Subjects Previously Exposed to BIVV003 or ST-400.". 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 ...
What is the current status of trial NCT05145062?
This trial is currently active not recruiting. The enrollment target is 8 participants. The study started on 2021-12-21. Estimated completion is 2038-07-14.
What conditions does trial NCT05145062 study?
This clinical trial studies the following conditions: Blood and Lymphatic Diseases.
What interventions are being tested in trial NCT05145062?
The interventions under investigation include: BIVV003 (DRUG), ST-400 (DRUG).
Who is sponsoring clinical trial NCT05145062?
This trial is sponsored by Sangamo Therapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05145062 being conducted?
This trial has 7 study locations across California, Georgia, Massachusetts, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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