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

Bader, Ted, M.D.

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: tamoxifen

Study type: Interventional

Identifiers

NCT00749138

102453081873

Details and patient eligibility

About

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.

Full description

Six different dosages of tamoxifen will be given for 14 days with safety and viral loads being measured.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

tamoxifen

Experimental group

Description:

open label giving of tamoxifen

Treatment:

Drug: tamoxifen