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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

VA Hospital

Oklahoma City, Oklahoma, 73104, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

HCV RNA positive.
failed standard therapy

Exclusion criteria

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 -

Treatment and study plan

Tamoxifen

Drug

giving drug tamoxifen

Other names: Nolvadex

Primary outcomes

No significant changes in ALT or total bilirubin

Time frame: 14 days

Secondary outcomes

HCV RNA reduction

Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Bader, Ted, M.D.

Indiv

Registry information

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Sep 9, 2008
Registry last updated: Mar 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed