Fourteen Day Safety of Low-Dose Tamoxifen in Patients With Chronic Hepatitis C Who Have Failed Standard Medical Therapy
This study has been completed.
Information provided by:
Bader, Ted, M.D.
First received: September 4, 2008
Last updated: March 7, 2010
Last verified: March 2010
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.
Chronic Hepatitis C
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Fourteen Day Safety of Low-Dose Tamoxifen in Patients With Chronic Hepatitis C Who Have Failed Standard Medical Therapy
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:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2009 (Final data collection date for primary outcome measure)
open label giving of tamoxifen
giving drug tamoxifen
Other Name: Nolvadex
Six different dosages of tamoxifen will be given for 14 days with safety and viral loads being measured.
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- HCV RNA positive.
- failed standard therapy
- 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 -
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749138
|Oklahoma City, Oklahoma, United States, 73104 |
Bader, Ted, M.D.
No publications provided
||Ted Bader, MD
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 4, 2008
||March 7, 2010
||United States: Food and Drug Administration
Keywords provided by Bader, Ted, M.D.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Hepatitis C, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents