Status:
COMPLETED
Fourteen Day Safety of Low-Dose Tamoxifen in Patients With Chronic Hepatitis C Who Have Failed Standard Medical Therapy
Lead Sponsor:
Bader, Ted, M.D.
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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.
Detailed Description
Six different dosages of tamoxifen will be given for 14 days with safety and viral loads being measured.
Eligibility Criteria
Inclusion
- HCV RNA positive.
- failed standard therapy
Exclusion
- Cirrhosis on biopsy
- Severe medical or psychiatric conditions that would make the evaluation difficult
- Tamoxifen is a pregnancy category D drug so pregnant women must be excluded.
- Patients with coumadin cannot be used from a drug interaction.
- Active use of alcohol or illegal substances -
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00749138
Start Date
November 1 2008
End Date
October 1 2009
Last Update
March 9 2010
Active Locations (1)
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1
VA Hospital
Oklahoma City, Oklahoma, United States, 73104