Fourteen Day Safety of Low-Dose Tamoxifen in Patients With Chronic Hepatitis C Who Have Failed Standard Medical Therapy

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

A short 14 day phase 1 study examining 6 monotherapy doses of oral tamoxifen for safety in chronic HCV patients who have failed standard treatment of peginterferon and ribavirin.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bader, Ted, M.D.
• Treatments: Tamoxifen

Criteria

Inclusion Criteria:

1. HCV RNA positive.

2. failed standard therapy

Exclusion Criteria:

1. Cirrhosis on biopsy

2. Severe medical or psychiatric conditions that would make the evaluation difficult

3. Tamoxifen is a pregnancy category D drug so pregnant women must be excluded.

4. Patients with coumadin cannot be used from a drug interaction.

5. Active use of alcohol or illegal substances -