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

This study has been completed.
Sponsor:
Information provided by:
Bader, Ted, M.D.
ClinicalTrials.gov Identifier:
NCT00749138
First received: September 4, 2008
Last updated: March 7, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Drug: tamoxifen
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fourteen Day Safety of Low-Dose Tamoxifen in Patients With Chronic Hepatitis C Who Have Failed Standard Medical Therapy

Resource links provided by NLM:


Further study details as provided by Bader, Ted, M.D.:

Primary Outcome Measures:
  • No significant changes in ALT or total bilirubin [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • HCV RNA reduction [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: November 2008
Study Completion Date: October 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tamoxifen
open label giving of tamoxifen
Drug: tamoxifen
giving drug tamoxifen
Other Name: Nolvadex

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749138

Locations
United States, Oklahoma
VA Hospital
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Bader, Ted, M.D.
Investigators
Principal Investigator: Ted Bader OUHSC
  More Information

No publications provided

Responsible Party: Ted Bader, MD
ClinicalTrials.gov Identifier: NCT00749138     History of Changes
Other Study ID Numbers: 102453081873
Study First Received: September 4, 2008
Last Updated: March 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bader, Ted, M.D.:
hepatitis C, tamoxifen

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Tamoxifen
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on April 16, 2014