Immunity Against AAV in Crigler Najjar Patient

NCT02302690 — Completed, 49 participants, Genethon

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Study of the Prevalence of Pre-existing Immunity Against the Adeno-associated Virus (AAV) in Patients With Crigler-Najjar Syndrome

Registry	NCT02302690
Status	Completed
Study type	Observational
Enrollment	49 (Actual)
Sponsor	Genethon (Other)
Conditions	Crigler Najjar Syndrome
Interventions	Blood sample for immunology (Biological)
Dates	start 2014-11-01, primary completion 2017-06-01, completion 2017-06-01, first posted 2014-11-27, last updated 2017-12-13
Locations	1 site in France

-Summary

The proposed research protocol aims at addressing these points by pre-screening CN patients for their AAV serology in link with their medical history and current medical status. A first objective is to assess the presence of neutralizing AAV antibodies in the serum of CN patients.

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+Arms and interventions

Blood sample for immunology (Biological)

+Outcome measures

Primary outcomes

To assess the presence of neutralizing AAV antibodies in the serum of CN patients [1 day visit]

+Eligibility

Sex: All

Inclusion Criteria:

* The patient has a Crigler-Najjar syndrome
* The molecular diagnosis has been confirmed by UGT1A1 gene DNA sequencing

Exclusion criteria:

* The patient is liver transplanted
* The patient is suffering from severe associated pathologies precluding further enrolment in a future interventional clinical study

+Locations (1)

Facility	City	Country	Status
Hopital Antoine Béclère	Clamart	France