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

Chronic Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749138
• Other study ID #: 102453081873
• Status: Completed
• Phase: Phase 1
• First received: September 4, 2008
• Last updated: March 7, 2010
• Start date: November 2008
• Est. completion date: October 2009

Study information

• Verified date: March 2010
• Source: Bader, Ted, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 -

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• tamoxifen
giving drug tamoxifen

Locations

Country	Name	City	State
United States	VA Hospital	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Bader, Ted, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No significant changes in ALT or total bilirubin		14 days	Yes
Secondary	HCV RNA reduction		14 days	No