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Long - Term Follow Up of Sickle Cell Disease and Beta-thalassemia Subjects Previously Exposed to BIVV003 or ST-400.
NCT05145062 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05145062
The ClinicalTrials.gov registry entry for NCT05145062 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sangamo Therapeutics, which has 10 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05145062 reports 7 study locations spanning 5 distinct geographic areas — top geographies include California, Michigan, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05145062?
The interventions under investigation include: BIVV003 (DRUG), ST-400 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05145062?
This trial is sponsored by Sangamo Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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