Immunity Against AAV in Crigler Najjar Patient

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Crigler Najjar Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Blood sample for immunology

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hopital Antoine Béclère

Clamart, , France

Site Status

Countries

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France

Other Identifiers

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CRIG-COL-01

Identifier Type: -

Identifier Source: org_study_id