Immunity Against AAV in Crigler Najjar Patient

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02302690

Enrollment

Registered

2014-11-27

Start date

2014-11-30

Completion date

2017-06-30

Last updated

2017-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crigler Najjar Syndrome

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.

Interventions

BIOLOGICALBlood sample for immunology

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026