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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00749138

Enrollment

Registered

2008-09-09

Start date

2008-11-30

Completion date

2009-10-31

Last updated

2010-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

hepatitis C, tamoxifen

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.

Interventions

DRUGtamoxifen

giving drug tamoxifen

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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 -

Design outcomes

Primary

Measure	Time frame
No significant changes in ALT or total bilirubin	14 days

Secondary

Measure	Time frame
HCV RNA reduction	14 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026