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

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ClinicalTrials.gov Identifier: NCT00749138
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : March 9, 2010
Sponsor:
Information provided by:
Bader, Ted, M.D.

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: tamoxifen Phase 1

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: tamoxifen
open label giving of tamoxifen
Drug: tamoxifen
giving drug tamoxifen
Other Name: Nolvadex



Primary Outcome Measures :
  1. No significant changes in ALT or total bilirubin [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. HCV RNA reduction [ Time Frame: 14 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ted Bader, MD
ClinicalTrials.gov Identifier: NCT00749138     History of Changes
Other Study ID Numbers: 102453081873
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: March 9, 2010
Last Verified: March 2010

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

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