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

September 4, 2008
March 7, 2010
November 2008
May 2009   (final data collection date for primary outcome measure)
No significant changes in ALT or total bilirubin [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00749138 on ClinicalTrials.gov Archive Site
HCV RNA reduction [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Fourteen Day Safety of Low-Dose Tamoxifen in Patients With Chronic Hepatitis C Who Have Failed Standard Medical Therapy
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.

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

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
Drug: tamoxifen
giving drug tamoxifen
Other Name: Nolvadex
Experimental: tamoxifen
open label giving of tamoxifen
Intervention: Drug: tamoxifen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
October 2009
May 2009   (final data collection date for primary outcome measure)

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 -
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00749138
102453081873
No
Ted Bader, MD
Bader, Ted, M.D.
Not Provided
Principal Investigator: Ted Bader OUHSC
Bader, Ted, M.D.
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP