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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE September 4, 2008
First Posted Date  ICMJE September 9, 2008
Last Update Posted Date March 9, 2010
Study Start Date  ICMJE November 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2008)
No significant changes in ALT or total bilirubin [ Time Frame: 14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2008)
HCV RNA reduction [ Time Frame: 14 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fourteen Day Safety of Low-Dose Tamoxifen in Patients With Chronic Hepatitis C Who Have Failed Standard Medical Therapy
Official Title  ICMJE Fourteen Day Safety of Low-Dose Tamoxifen in Patients With Chronic Hepatitis C Who Have Failed Standard Medical Therapy
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.
Detailed Description Six different dosages of tamoxifen will be given for 14 days with safety and viral loads being measured.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C
Intervention  ICMJE Drug: tamoxifen
giving drug tamoxifen
Other Name: Nolvadex
Study Arms  ICMJE Experimental: tamoxifen
open label giving of tamoxifen
Intervention: Drug: tamoxifen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 5, 2008)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00749138
Other Study ID Numbers  ICMJE 102453081873
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ted Bader, MD
Study Sponsor  ICMJE Bader, Ted, M.D.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ted Bader OUHSC
PRS Account Bader, Ted, M.D.
Verification Date March 2010

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