Immunity Against AAV in Crigler Najjar Patient

Completed

• Conditions: Crigler Najjar Syndrome

• Registration Number: NCT02302690
• Lead Sponsor: Genethon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-25
• Study First Submitted QC: 2014-11-26
• Study First Posted: 2014-11-27
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-12
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the presence of neutralizing AAV antibodies in the serum of CN patients	1 day visit

Trial Locations

Locations (1)

Hopital Antoine Béclère; 🇫🇷 Clamart, France