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:
Bader, Ted, M.D.
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
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis C |
Drug: tamoxifen |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Bader, Ted, M.D.:
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: | 18 |
| Study Start Date: | November 2008 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: tamoxifen
open label giving of tamoxifen
|
Drug: tamoxifen
giving drug tamoxifen
Other Name: Nolvadex
|
Detailed Description:
Six different dosages of tamoxifen will be given for 14 days with safety and viral loads being measured.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 -
Contacts and Locations More Information
No publications provided
| Responsible Party: | Ted Bader, MD |
| ClinicalTrials.gov Identifier: | NCT00749138 History of Changes |
| Other Study ID Numbers: | 102453081873 |
| Study First Received: | September 4, 2008 |
| Last Updated: | March 7, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bader, Ted, M.D.:
|
hepatitis C, tamoxifen |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
Tamoxifen Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists |
ClinicalTrials.gov processed this record on May 21, 2013