Active — Not RecruitingNot Applicable

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

United States8 participantsStarted 2021-12-21

Plain-language 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

Who can participate

Age range18 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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.

What they're measuring

Adverse Events

Timeframe: Up to 15 years

Overall Survival

Timeframe: Up to 15 years

Trial details

NCT IDNCT05145062

SponsorSangamo Therapeutics

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2038-07-14

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