Clinical Trial Drug Study for Primary Sclerosing Cholangitis (PSC)

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"Investigational Drug for Subjects with Primary Sclerosing Cholangitis Without Cirrhosis"
Age:
18 - 70
Gender:
Any
Healthy Volunteers:
No
Keywords:
liver, psc, primary sclerosing cholangitis
Type:
Phase 2 Drug Study
Target:
5 Participants
Investigator:
Description
The purpose of this study is to find out if GS-9674 is safe and well tolerated in patients with primary sclerosing cholangitis. GS-9674 is an investigational drug being developed to reduce bile acids, which may be increased and cause damage to the liver of patients with PSC.

There are three parts to the study: Screening, Blinded Treatment, and Open-Label Treatment. During the Blinded Treatment, patients will receive either GS-9674 or a placebo (sugar pill). Neither the patient nor the investigator will know if the patient is getting GS-9674 or placebo. During the optional Open-Label Treatment, patients will receive GS-9674 for up to 2 years.
This study requires
• 8 visits to the Gastroenterology and Hepatology Clinical Trial Unit during the Screening and Blinded Treatment parts of the study and 14 visits during the optional Open-Label Treatment part of the study
• Take GS-9674 or placebo by mouth once daily
• Imaging, blood draws, urine collection, and questionnaires at study visits
Who can participate?
Males and females between 18-70 years of age with non-cirrhotic Primary Sclerosing Cholangitis (PSC)
Compensation
Compensation is provided for your travel, time, and effort.
Resources
Schedule
Study duration and period
Screening must be completed within 4 weeks. Blinded Treatment will last about 4 months. The optional Open-Label Treatment will last up to 2 years. One last follow up visit will occur 4 weeks after treatment. Research visits can be coordinated with scheduled doctor visits.
Recruitment period
From July 18, 2017 to May 31, 2018
Location
UC Davis GI and Hepatology Clinical Trial Unit
2000 Stockton Boulevard
Suite 100B
Sacramento, CA 95817
Contact
Sandeep Dhaliwal

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