Status:

WITHDRAWN

Retroviral Insertion Site Methodology Study

Lead Sponsor:

Fondazione Telethon

Conditions:

Immune System Diseases

Eligibility:

All Genders

Phase:

PHASE4

Brief Summary

Adenosine deaminase (ADA) is an enzyme involved in the development and functioning of the immune system. Deficiency of ADA results in severe combined immunodeficiency (SCID), a fatal inherited immune ...

Eligibility Criteria

Inclusion

  • Male or female, pediatric or adult, subjects with ADA-SCID, who have been previously treated with Strimvelis.
  • Capable of giving signed informed consent or signed informed consent provided by the subject's parent or legal guardian.

Exclusion

  • Presence of concomitant condition(s) that in the Investigator's opinion makes participation in the study unsuitable or may prevent compliance with the protocol requirements.
  • Unlikely to comply with the requirements of the protocol (i.e. attendance for blood sampling on an approximately annual basis).
  • Transportation of viable samples to the European Union (EU) central laboratory from the subject's home country is not possible.

Key Trial Info

Start Date :

June 25 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 9 2020

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT03311074

Start Date

June 25 2020

End Date

July 9 2020

Last Update

January 29 2024

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