Clinical Assessment Study in Crigler-Najjar Syndrome

Completed

Conditions studied: Crigler-Najjar Syndrome

In brief

This is a Pre-Phase 1 prospective, non-interventional clinical assessment study to evaluate Crigler-Najjar syndrome subjects requiring daily phototherapy, aged 1 year and older.

Key facts

Study ID

NCT03078881

Run by

Audentes Therapeutics

People needed

8

Starts

2017-03-10

Expected to finish

2019-01-23

Last updated by the study team

2019-02-06

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subject is currently participating in an interventional study or has received gene or cell therapy
• Subject has received a whole liver, partial liver, or hepatocyte transplant; or subject has a liver transplant scheduled within the planned participation period of this study
• Subject has significant cholestatic disease, in the opinion of the investigator
• Subject is receiving phenobarbital or other known inducer of UGT1A1 within 30 days of screening
• Subject has any clinically significant underlying liver disease (other than Crigler-Najjar syndrome), in the opinion of the investigator
• Subject has a history of, or currently has, a clinically important condition other than Crigler-Najjar syndrome, in the opinion of the investigator

Where it is running

• Children's Hospital at Montefiore — The Bronx, New York, United States
• Clinic for Special Children — Strasburg, Pennsylvania, United States
• Shaare Zedek Medical Center — Jerusalem, Israel
• King's College Hospital — London, England, United Kingdom

Full record on ClinicalTrials.gov

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