Back to resultsFourteen Day Safety of Low-Dose Tamoxifen in Patients With Chronic Hepatitis C Who Have Failed Standard Medical Therapy
Primary Purpose
Chronic Hepatitis C
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
tamoxifen
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring hepatitis C, tamoxifen
Eligibility Criteria
Inclusion Criteria:
- HCV RNA positive.
- failed standard therapy
Exclusion Criteria:
- Cirrhosis on biopsy
- Severe medical or psychiatric conditions that would make the evaluation difficult
- Tamoxifen is a pregnancy category D drug so pregnant women must be excluded.
- Patients with coumadin cannot be used from a drug interaction.
- Active use of alcohol or illegal substances -
Sites / Locations
- VA Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
tamoxifen
Arm Description
open label giving of tamoxifen
Outcomes
Primary Outcome Measures
No significant changes in ALT or total bilirubin
Secondary Outcome Measures
HCV RNA reduction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00749138
Brief Title
Fourteen Day Safety of Low-Dose Tamoxifen in Patients With Chronic Hepatitis C Who Have Failed Standard Medical Therapy
Official Title
Fourteen Day Safety of Low-Dose Tamoxifen in Patients With Chronic Hepatitis C Who Have Failed Standard Medical Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bader, Ted, M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
hepatitis C, tamoxifen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tamoxifen
Arm Type
Experimental
Arm Description
open label giving of tamoxifen
Intervention Type
Drug
Intervention Name(s)
tamoxifen
Other Intervention Name(s)
Nolvadex
Intervention Description
giving drug tamoxifen
Primary Outcome Measure Information:
Title
No significant changes in ALT or total bilirubin
Time Frame
14 days
Secondary Outcome Measure Information:
Title
HCV RNA reduction
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HCV RNA positive.
failed standard therapy
Exclusion Criteria:
Cirrhosis on biopsy
Severe medical or psychiatric conditions that would make the evaluation difficult
Tamoxifen is a pregnancy category D drug so pregnant women must be excluded.
Patients with coumadin cannot be used from a drug interaction.
Active use of alcohol or illegal substances -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ted Bader
Organizational Affiliation
OUHSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Fourteen Day Safety of Low-Dose Tamoxifen in Patients With Chronic Hepatitis C Who Have Failed Standard Medical Therapy
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