A Phase III, Multicentre, Double Blinded Study In Patients With Chronic Hepatitis C Who Are Non-Responders To Prior Peginterferon Alpha + Ribavirin Therapy Comparing Treatment With Thymosin Alpha 1 + Peginterferon Alpha-2a Plus Ribavirin With Peginterferon Alpha-2a + Ribavirin + Placebo
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 552
- 试验地点
- 9
- 主要终点
- Sustained Virological Response (SVR)
研究概览
简要总结
The purpose of the study was to determine safety and efficacy of 48 weeks treatment with Thymosin alpha 1 (Talpha1) in combination with pegylated interferon (PEGIFN) alpha2a and ribavirin (RBV) in adult patients with chronic hepatitis C (CHC) already treated with, and not responding to previous courses of PEGIFN alpha plus RBV combination therapy, in comparison with a concurrent group treated with PEG IFN alpha2a in combination with RBV and placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Presence of HCV RNA measured by quantitative PCR
- •Non responder to previous approved doses of therapy with PEGinterferon alpha plus ribavirin. Patients must have been treated for at least 12 weeks with documented HCV RNA quantitative not showing major of 2 log10 HCV RNA reduction or patients treated for at least 24 weeks with documented HCV RNA qualitative not showing a virological response (viral RNA clearance)
- •Liver biopsy consistent with a diagnosis of chronic hepatitis C or histological cirrhosis. Biopsy will not be required if the patient can produce a biopsy performed within the year preceding the randomization day and was performed at least 6 months after the end of the latter course of therapy
- •Wash-out period of at least 6 months from previous therapy with PEGinterferon alpha plus ribavirin
- •Negative pregnancy test prior (no more than 24 hours) to first study medication dose
排除标准
- •Use of systemic corticosteroids within 6 months of entry
- •More than one previous course of therapy with PEGinterferon alpha plus ribavirin
- •Any other liver disease
- •Decompensated liver disease based on a history of hepatic encephalopathy, bleeding oesophageal varices, or ascites
- •Decompensate or advanced liver cirrhosis (ChildPugh B or C)
- •HIV infection diagnosed by HIV seropositivity and confirmed by Western blot
- •Insulin-dependent Diabetes Mellitus
- •Severe haemoglobinopathy
- •Positive liver and kidney microsomal auto antibodies
- •Positive anti thyroid antibodies
- •Pregnancy as documented by a urine pregnancy test
- •Alcohol or intravenous drug abuse within the previous 1 year
- •Patients who are in poor medical or psychiatric conditions, or who have any non-malignant systemic disease that, in the opinion of the Investigator, would make it unlikely that the patient could complete the study protocol
- •Any indication that the patient would not comply with the conditions of the study protocol
- •Previous treatment with thymosin alpha 1
- •Patients with known hypersensitivity to any PEGinterferon and or ribavirin
- •Patients with a history of severe depression that required either hospitalization or electroshock therapy or depression associated with suicide attempt
- •Simultaneous participation in another investigational drug study or participation in any clinical trial involving investigational drugs within 3 months before study entry
- •Presence of serious pulmonary or cardiovascular disorders
研究组 & 干预措施
Thymosin alpha 1
Patients affected by chronic hepatitis C not responding to a course with approved doses of PEGinterferon alpha plus ribavirin therapy (i.e. at least 1.0 mcg/kg PEGinterferon alpha2b, 180 mcg PEGinterferon alfa2a, 800 mg ribavirin).
干预措施: Thymosin alpha 1 (Biological)
Thymosin alpha 1
Patients affected by chronic hepatitis C not responding to a course with approved doses of PEGinterferon alpha plus ribavirin therapy (i.e. at least 1.0 mcg/kg PEGinterferon alpha2b, 180 mcg PEGinterferon alfa2a, 800 mg ribavirin).
干预措施: Ribavirin (Drug)
Thymosin alpha 1
Patients affected by chronic hepatitis C not responding to a course with approved doses of PEGinterferon alpha plus ribavirin therapy (i.e. at least 1.0 mcg/kg PEGinterferon alpha2b, 180 mcg PEGinterferon alfa2a, 800 mg ribavirin).
干预措施: PEGinterferon alfa2a (Biological)
Placebo
Patients affected by chronic hepatitis C not responding to a course with approved doses of PEGinterferon alpha plus ribavirin therapy (i.e. at least 1.0 mcg/kg PEGinterferon alpha2b, 180 mcg PEGinterferon alfa2a, 800 mg ribavirin).
干预措施: Ribavirin (Drug)
Placebo
Patients affected by chronic hepatitis C not responding to a course with approved doses of PEGinterferon alpha plus ribavirin therapy (i.e. at least 1.0 mcg/kg PEGinterferon alpha2b, 180 mcg PEGinterferon alfa2a, 800 mg ribavirin).
干预措施: PEGinterferon alfa2a (Biological)
Placebo
Patients affected by chronic hepatitis C not responding to a course with approved doses of PEGinterferon alpha plus ribavirin therapy (i.e. at least 1.0 mcg/kg PEGinterferon alpha2b, 180 mcg PEGinterferon alfa2a, 800 mg ribavirin).
干预措施: Placebo (Drug)
结局指标
主要结局
Sustained Virological Response (SVR)
时间窗: Week 72
The proportion of patients who were HCV RNA negative at the end of observation period.
次要结局
- Sustained Biochemical Response (SBR)(Week 72)
- End of Treatment Biochemical Response (EBR)(Week 48)
- End of Treatment Virological Response [EVR](Week 48)
- Safety(During the treatment period (up to 48 weeks) and the follow-up period (up to 24 weeks))