A Greek Observational Study on Relapse Rate and Sustained Virological Response in Naive CHC Patients, Treated With Pegylated Interferon Alpha-2b and Ribavirin in Daily Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 332
- 主要终点
- Number of Participants Who Demonstrated Virological Relapse as Assessed at 24-week Post-treatment Follow-up
研究概览
简要总结
The objective of the study is to evaluate the rates of Hepatitis C virus (HCV) eradication and relapse in participants treated with PegIntron and Rebetol in clinical practice in Greece. Participants will not be treated as part of the study. Data on participants treated in accordance with approved labeling will be collected retrospectively from approximately 30 sites in Greece.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Participants who have already begun Summary of Product Characteristics (SmPC)-based combination treatment with pegylated interferon alpha-2b and ribavirin, prior to the site initiation date.
- •Participants who have been receiving combination treatment with pegylated interferon alpha-2b and ribavirin for at least 6 months before enrollment.
- •Participants who have achieved negative HCV RNA at the end of treatment, defined according to genotype (24 weeks for HCV genotypes 2/3 and 48 weeks for genotypes 1/4).
- •Participants with diagnosed chronic hepatitis C (CHC) and HCV genotype 1, 2, 3 or
- •Participants older than 18 years, regardless of gender or race.
排除标准
- •The participant has received treatment for CHC in the past (not treatment-naive).
- •The participant has received treatment in the context of a clinical trial in the participating site.
- •The participant has been diagnosed with a concomitant infection e.g. with hepatitis B or HIV
- •The participant has de-compensated liver disease or belongs to a special population, such as liver transplant, hemophilia, severe pre-existing psychiatric disorder, auto-immune disease, thalassaemia.
- •The participant has positive HCV RNA at the end of treatment.
- •Pregnant women or women intending to bear children or sexual partners of women wishing to bear children and for a 7-month period after the end of treatment, as indicated in the SmPC of Rebetol.
- •The participant is not eligible on grounds of contra-indications, special warnings, particular population and/or the section on pregnancy and lactation of the SmPC.
- •The participant has interrupted treatment for any reason.
研究组 & 干预措施
Participants with Chronic Hepatitis C
Treatment-naïve participants with chronic hepatitis C, undergoing treatment with a standard treatment regimen of PegIntron and Rebetol in clinical practice at approximately 28 sites in Greece
干预措施: PegIntron (peginterferon alfa-2b, pegylated interferon alfa-2b) (Biological)
Participants with Chronic Hepatitis C
Treatment-naïve participants with chronic hepatitis C, undergoing treatment with a standard treatment regimen of PegIntron and Rebetol in clinical practice at approximately 28 sites in Greece
干预措施: Rebetol (ribavirin) (Drug)
结局指标
主要结局
Number of Participants Who Demonstrated Virological Relapse as Assessed at 24-week Post-treatment Follow-up
时间窗: 24 weeks following completion of 24 or 48 weeks of therapy
Virological relapse was assessed at the 24-week post-treatment follow-up (Visit 2). Virological relapse was defined as undetectable plasma HCV-RNA at end of combination treatment (Visit 1- considered Week 24 or Week 48 after treatment start depending on treatment duration), but with positive HCV-RNA at the 24-week post treatment follow-up.
Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up
时间窗: 24 weeks following completion of 24 or 48 weeks of therapy
Sustained virological response (SVR) was assessed at the 24-week post-treatment follow-up (Visit 2). SVR was defined as undetectable plasma Hepatitis C virus Ribonucleic acid (HCV-RNA) at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).
次要结局
- Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Liver Fibrosis Stage at Baseline(24 weeks following completion of 24 or 48 weeks of therapy)
- Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV-RNA Viral Load at Baseline(24 weeks following completion of 24 or 48 weeks of therapy)
- Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV Genotype at Baseline(24 weeks following completion of 24 or 48 weeks of therapy)
- Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Alanine Aminotransferase (ALT) Levels at Baseline(24 weeks following completion of 24 or 48 weeks of therapy)
- Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Study Treatment Dosage Modification(24 weeks following completion of 24 or 48 weeks of therapy)
- Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Achievement of Rapid Virological Response(24 weeks following completion of 24 or 48 weeks of therapy)
- Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Compliance With the 80/80/80 Rule(24 weeks following completion of 24 or 48 weeks of therapy)