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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Pioglitizone and Atorvastatin
Pioglitazone and Atorvastatin added to standard of care Pegasys and weight based ribavirin
干预措施: pioglitazone (Actos) (Drug)
Pioglitizone and Atorvastatin
Pioglitazone and Atorvastatin added to standard of care Pegasys and weight based ribavirin
干预措施: atorvastatin (Lipitor) (Drug)
结局指标
主要结局
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.
时间窗: 36 weeks
次要结局
未报告次要终点
研究者
Stephen A Harrison
Principal Investigator
Brooke Army Medical Center