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

March 7, 2010 updated by: Bader, Ted, M.D.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • VA Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tamoxifen
open label giving of tamoxifen
Drug: tamoxifen
giving drug tamoxifen
Other Names:
  • Nolvadex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
No significant changes in ALT or total bilirubin
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
HCV RNA reduction
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bader, Ted, M.D.

Investigators

  • Principal Investigator: Ted Bader, OUHSC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

September 4, 2008

First Submitted That Met QC Criteria

September 5, 2008

First Posted (Estimate)

September 9, 2008

Study Record Updates

Last Update Posted (Estimate)

March 9, 2010

Last Update Submitted That Met QC Criteria

March 7, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102453081873

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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