NCT00953615

Thalidomide for the Treatment of Primary Sclerosing Cholangitis (PSC)

Open Label, Phase II Investigation of Thalidomide for the Treatment of Primary Sclerosing Cholangitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and benefit of Thalidomide with primary sclerosing cholangitis (PSC). This is a six month study.

Detailed description

At entry, patients will have a complete history and physical, blood tests, ultrasound, and will complete questionnaires. Eligible patients will take Thalidomide 400 mg once a day in the evening. Patients will start a dose of 100 mg per day for two weeks, increasing by 100 mg per day every two weeks to a maximum dose of 400 mg per day for 6 months. Patients will return at 6 months for an evaluation, blood tests and completion of questionnaires. Blood tests will be performed by mailed-in kits at 3 months. Patients will receive weekly phone calls for the first 2 months and bi-monthly thereafter.

Conditions

• Primary Sclerosing Cholangitis

Interventions

Type	Name	Description
DRUG	Thalidomide	Titrate to 400 mg daily for 6 months

Timeline

• Start date: 2006-04-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2009-08-06
• Last updated: 2012-02-27
• Results posted: 2012-02-27

Locations

1 site across 1 country: United States