Observational Multicenter Study to Evaluate Influence of Insulin Resistance on the Safety and Efficacy (as Measured by Sustained Virological Response) of Treatment With Any Pegylated Interferon and Ribavirin (Standard of Care) in Different Populations of HCV Patients in Russia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 主要终点
- Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study
研究概览
简要总结
Naïve patients with chronic hepatitis C (CHC) of any genotype will be treated with a standard treatment regimen (pegylated interferon and ribavirin) according to routine clinical practice in Russia. The objective of this study is to examine the influence of insulin resistance on the safety and efficacy of treatment with pegylated interferon and ribavirin and to determine the prevalence of insulin resistance in different populations of CHC patients.
详细描述
consecutive patient sampling
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Confirmed diagnosis of CHC according to local regulations
- •Naïve Pegylated Interferon (PEG-IFN) CHC patient
- •No contraindications for PEG-IFN CHC therapy
- •Negative urine pregnancy test result (for females of childbearing potential) documented within the 24-hour period prior to the first dose of study drugs. Additionally, all female patients of childbearing potential and all males with female partners of childbearing potential must use two forms of effective contraception (combined) during treatment and 6 months after treatment end
- •Willingness to give written informed consent and willingness to participate in and comply with the study requirements.
排除标准
- •PEG-IFN treatment in history
- •Contraindications for PEG-IFN CHC therapy
- •Females who are pregnant or breast-feeding
- •Male partners of females who are pregnant
- •Potentially unreliable participants, and those judged by the investigator to be unsuitable for the study.
研究组 & 干预措施
Patients with chronic hepatitis C
Naïve patients with chronic hepatitis C (CHC) of any genotype will be treated with a standard treatment regimen (pegylated interferon and ribavirin) according to routine clinical practice in Russia.
干预措施: Pegylated Interferon (Biological)
Patients with chronic hepatitis C
Naïve patients with chronic hepatitis C (CHC) of any genotype will be treated with a standard treatment regimen (pegylated interferon and ribavirin) according to routine clinical practice in Russia.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study
时间窗: 24 weeks following completion of 24 or 48 weeks of therapy
Sustained Virological response (SVR) was assessed at the end of the study (Visit 4) to investigate the presence or absence of SVR. SVR was defined as undetectable plasma hepatitis C virus RNA (HCV-RNA) at 24 weeks after termination of treatment. Visit 4 was considered Week 48 or Week 72 depending on a treatment duration of 24 or 48 weeks respectively.
次要结局
- Percentage of Participants Who Achieved Sustained Virological Response as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline(24 weeks following completion of 24 or 48 weeks of therapy)
- Percentage of Participants Who Achieved Response Following Treatment as Assessed at End of Treatment by HCV Genotype and Presence of Insulin-Resistance at Baseline(Week 24 or 48 after treatment start)
- Percentage of Participants Who Demonstrated Virological Relapse as Assessed at End of Study by HCV Genotype and Presence of Insulin-Resistance at Baseline(24 weeks following completion of 24 or 48 weeks of therapy)
- Percentage of Participants Who Achieved Early Virological Response as Assessed at Visit 2 by HCV Genotype and Presence of Insulin-Resistance at Baseline(Week 12 after treatment start)