NCT00084279已完成2 期
Safety and Tolerability of Consensus Interferon-Alpha (CIFN) Plus Interferon Gamma-1b (IFN-γ 1b) With or Without Ribavirin (RBV) in the Treatment of Patients With Chronic Hepatitis C Who Are Non-Responders to PEG-IFN-a (2a or 2b) Plus RBV
InterMune2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2004年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Virologic response defined as >2 log (base 10) reduction in HCV RNA
研究概览
简要总结
To evaluate the safety and tolerability of two different doses of Consensus Interferon-Alpha and Interferon Gamma-1b with or without ribavirin in patients with chronic hepatitis C who are non-responders to PEG-IFN-a 2a or PEG-IFN-a 2b plus ribavirin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Signed, written, informed consent from the patient or legal representative before any study-specific procedures are performed
- •Male or female 18 years of age or older
- •Chronic hepatitis C infection based on history of positive serum anti-HCV antibody and/or HCV RNA
- •Patients must have documented failure to respond to past treatment with PEG-Intron or Pegasys plus RBV.
- •Liver biopsy within 3 years of screening documenting chronic liver disease consistent with chronic hepatitis C
排除标准
- •Patients with any history of decompensated liver disease including but not restricted to portal hypertension as manifested by gastroesophageal varices, variceal bleeding, ascites, or encephalopathy
- •Specific laboratory abnormalities at Screening
- •Patients who were HCV RNA negative during prior pegylated interferon plus ribavirin treatment, but who relapsed during follow-up
- •Recent depression or psychiatric disorders
- •Known HIV infection or positive HIV antibody test at Screening
- •Chronic hepatitis B infection or positive hepatitis B surface antigen (HBsAg) at Screening
- •Unstable or uncontrolled thyroid disease
- •Presence or history of non-HCV chronic liver disease
- •History of unstable or deteriorating cardiovascular or cerebrovascular disease within 6 months prior to Screening
- •Current or history of neurologic disorder within a specified time frame
- •A disease known to cause significant alteration in immunologic function including hematological malignancy, sarcoidosis or autoimmune disorder (e.g. rheumatoid arthritis, systemic lupus erythematosis, leukemia, lymphoma, autoimmune thyroid disease, scleroderma, psoriasis, inflammatory bowel disease, multiple sclerosis etc.)
- •History of major organ transplantation (i.e., liver, kidney, lung, or heart) with an existing functional graft, including bone marrow transplant or stem cell transplant
- •Concurrent therapy with immunosuppressive drugs or cytotoxic agents such as cyclosporine, azathioprine, chronic systemic corticosteroids, or chemotherapeutic agent(s) (e.g., cyclophosphamide, methotrexate, or cancer chemotherapy) or radiation therapy
- •Pregnant or lactating women
- •Liver biopsy within the past three years documenting cirrhosis
结局指标
主要结局
Virologic response defined as >2 log (base 10) reduction in HCV RNA
时间窗: 72 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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