Treatment of Cholestatic Pruritus With Sertraline

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Liver Cirrhosis, Biliary; Hepatitis C; Pruritus

Treatments: Drug: sertraline

Study type: Interventional

Funder types: NIH

Identifiers

NCT00058903

TRCPWS (completed)

Details and patient eligibility

About

The goal of this study is to find an effective and well-tolerated medical therapy for itching due to liver disease. Persons with primary biliary cirrhosis or chronic hepatitis C are currently being enrolled in the study. Persons participating in the study are given sertraline, a medication which is also often used for depression,to treat their itching. The dose is gradually increased as the effect on itching and any other potential side effects are carefully monitored.

Enrollment: 40 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Itching for at least 3 months
• Primary biliary cirrhosis or hepatitis C
• Elevated alkaline phosphatase for at least 6 months

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)