Efficacy of Actos Lipitor Pegasys & Ribavirin in CHC GT 1 Patients Who Relapsed or Nonresponded to Peg/Riba

Hepatitis c Clinical Trial

Official title:

48 Week Pilot Trial Assessing the Efficacy of Pioglitazone, Atorvastatin, Pegasys and Weight Based Ribavirin in Chronic Hepatitis C, Genotype 1 Patients Who Have Previously Relapsed or Did Not Respond to PegInterferon /Ribavirin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00926614
• Other study ID #: C.2008.153
• Status: Completed
• Phase: Phase 4
• First received: June 22, 2009
• Last updated: February 13, 2012
• Start date: September 2008
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The aim of the study will be to determine if an insulin sensitizing thiazolidinedione plus a lipid lowering agent (statin) improves sustained virologic response rates in patients who have previously not responded or relapsed on standard pegylated interferon and ribavirin therapy.

Description:

The study will evaluate the use of atorvastatin and pioglitazone in the pre-treatment of insulin resistance and lipid levels prior to the addition of pegylated interferon and ribavirin for chronic hepatitis C (CHC). If improvement is seen in insulin resistance patients may then be in a position to respond more favorably to current antiviral therapy consisting of pegylated interferon and ribavirin.

This study could demonstrate the value of pretreating and continuing treatment for insulin resistance with pioglitazone in CHC, genotype 1 patients who have previously not responded or relapsed to prior pegylated interferon and ribavirin treatment. Changes in lipids are not a primary or secondary endpoint in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• GT 1 previously treated with pegylated interferon & ribavirin & either non-responded or relapsed after cessation of therapy

• Insulin resistance

• Compensated liver disease

• WBC < 3,000/ mm3

• Neutrophil count < 1,500/mm3

• Platelets < 65,000/ mm3

• Albumin > 3 gm/dL

Exclusion Criteria:

• Participants on metformin or other thiazolidinedione must have 3month wash-out period

• Women who are pregnant or breast-feeding

• Males with pregnant partners

• Co-infection with HAV, HBV, or HIV

• Ophthalmic abnormalities such as severe retinopathy

• Poorly controlled thyroid dysfunction

• Serum creatinine concentration > 1.5 times ULN

• Severe psychiatric or neuropsychiatric disorders

• History of alcoholism or drug addiction 1 year prior to screening

• Seizure disorders not controlled with medication

• Significant cardiovascular dysfunction within the past 12 months

• Chronic pulmonary disease

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Drug:
• pioglitazone (Actos)
pioglitazone 30 mg qd for 30 days, then increase to 45 mg
• atorvastatin (Lipitor)
atorvastatin 40 mg for 30 days then increase to 80 mg daily

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement is seen in insulin resistance patients to be in a position to respond more favorably to current antiviral therapy consisting of pegylated interferon and ribavirin.		36 weeks	No