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

Bader, Ted, M.D.18 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis C

Interventions

tamoxifenDRUG

giving drug tamoxifen

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 -

Locations (1)

VA Hospital

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

No significant changes in ALT or total bilirubin

Time frame: 14 days

Secondary Outcomes

HCV RNA reduction

Time frame: 14 days

Data from ClinicalTrials.gov

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