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

Completed · Phase 4

Conditions studied: Hepatitis c

In brief

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.

Key facts

Study ID

NCT00926614

Run by

Brooke Army Medical Center

People needed

20

Starts

2008-09-01

Expected to finish

2011-12-01

Last updated by the study team

2012-02-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Brooke Army Medical Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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