An Open, Randomized, Multicentre Trial to Evaluate Efficacy and Safety of a 24-week Course of PEG-Interferon Alpha-2b Versus a 12-week Course of PEG-Interferon Alpha-2b Alone or Plus Ribavirin in Patients With Acute Hepatitis C
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 主要终点
- Number of Participants With Sustained Response (SR) at the End of the 6-month Follow-up Period
研究概览
简要总结
The objective of this study is to evaluate the efficacy of three regimens of pegylated interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in participants with acute hepatitis C. After 12 weeks of observation from disease onset, participants will receive one of the following regimens: (1) a 24-week course of PEG-IFN monotherapy (PEG-IFN 24); or (2) a 12-week course of PEG-IFN monotherapy (PEG-IFN-12); or (3) a 12-week course of PEG-IFN in combination with ribavirin (PEG-IFN + RVB 12). After the treatment period, participants will enter a 12-month follow-up.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with acute hepatitis C virus (HCV).
- •Normal and Elevated serum alanine transferase (ALT) levels
- •Positive serum HCV-RNA.
- •Aged between 18 and 65 years.
- •Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the drug. Additionally, all fertile males with partners of childbearing age and females must be using reliable contraception during the study and additionally for participants treated with ribavirin, for 6 months (for woman) and 7 months (for man and his partner) after treatment completion
排除标准
- •Liver disease unrelated to HCV infection
- •Hemoglobin (Hgb) <12g/dL in women and <13g/dL in men; white blood cells (WBC) <3,000/uL; platelets (PLTs) <100,000/ul
- •Women with ongoing pregnancy or who are breast feeding
- •History of severe psychiatric disease, especially depression
- •History of neurologic disease, especially epilepsy
- •History or evidence of symptoms of severe cardiac, gastrointestinal and kidney disease
- •Positive anti-Human Immunodeficiency Virus (HIV) antibodies
- •Positive anti-nuclear antibodies (ANA) and/or Anti-Smooth Muscle Antibody (ASMA) (>1/80)
- •Positive Hepatitis B surface antigen (HBsAg)
- •History of having received any systemic anti-neoplastic or immunomodulatory treatment in the previous 6 months
- •History or other evidence of severe illness or any other conditions which would make the participants, in the opinion of investigator, unsuitable for the study (active drug addict except those under methadone treatment, thalassemic, dyalized included)
研究组 & 干预措施
PEG-IFN 24
pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
干预措施: Pegylated interferon alfa-2b (Biological)
PEG-IFN 12
pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
干预措施: Pegylated interferon alfa-2b (Biological)
PEG-IFN + RVB 12
pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin at the dose of 10.6 mg/kg/day for 12 weeks
干预措施: Pegylated interferon alfa-2b (Biological)
PEG-IFN + RVB 12
pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin at the dose of 10.6 mg/kg/day for 12 weeks
干预措施: Ribavirin (Drug)
结局指标
主要结局
Number of Participants With Sustained Response (SR) at the End of the 6-month Follow-up Period
时间窗: Evaluated at the end of 6 months
SR was defined as serum Hepatitis C Virus (HCV RNA) level at the end of 6-month follow-up below 15 IU/mL.
次要结局
- Virologic Response at the End of Treatment Follow-up (ETR)(At the end of treatment (either 12 weeks or 24 weeks depending on randomization).)
- Virologic Response at 12 Months Post-treatment Follow-up (Long-term Response, [LTR]).(At 12 months post-treatment (treatment period either 12 weeks or 24 weeks depending on randomization).)
- Number of Participants With Rapid Virologic Response (RVR)(Evaluated at 2 and 4 weeks of treatment)
- Number of Participants Presenting With Alanine Transferase (ALT) Level Normalization(Evaluated at end of treatment (either 12 weeks or 24 weeks, depending on randomization), at 6-month follow-up visit, or at 12-month follow-up visit.)
- Number of Peripheral Blood Mononuclear Cells (PBMCs)(Treatment Weeks 2, 4, 8, and 12)