Evaluation of Rapid Virological Response in HCV Patients Treated With PegIntron and Ribavirin - APEGIN Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,146
- 主要终点
- Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment
研究概览
简要总结
The objective of the study is to evaluate, in each group, the number of participants who achieve rapid virological response (RVR) after 4 weeks treatment with PegIntron and Rebetol. The study will also assess whether RVR is a reliable predictor of sustained virologic response (defined as undetectable viral load at 24 weeks post-treatment).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to participate in the study and sign the Informed Consent Form
- •Established HCV infection, confirmed by molecular biology test (positive qualitative polymerase chain reaction [PCR] test)
- •Can be treatment-naïve, have retreatment, or co-infected with HIV
- •Be under treatment with PegIntron in combination with ribavirin, starting up to 14 days before the screening visit
排除标准
- •Participants who have not confirmed their willingness to participate in the study or have refused to sign the Free and Informed Consent Form
- •Prior treatment with PegIntron (combined with ribavirin or not)
- •History of alcohol abuse in the past 6 months
- •Decompensated liver disease
- •Severe heart disease
- •Decompensated thyroid disorder
- •Neoplasia
- •Type 1 diabetes mellitus - uncontrolled or hardly controlled
- •Seizures - uncontrolled
- •Primary immune deficiency
- •Men and women not using appropriate contraceptive methods
- •Pregnancy or lactation
- •For participants co-infected with HIV: HIV-related opportunistic disease in the past 6 months or CD4 count lower than 200 cells/mm^3
研究组 & 干预措施
Mono-infected with HCV
Participants infected with Hepatitis C Virus (HCV).
干预措施: PegIntron (peginterferon alfa-2b; SCH 54031) (Biological)
Mono-infected with HCV
Participants infected with Hepatitis C Virus (HCV).
干预措施: Rebetol (ribavirin; SCH 18908) (Drug)
Co-infected with HCV and HIV
Participants co-infected with HCV and Human Immunodeficiency Virus (HIV).
干预措施: PegIntron (peginterferon alfa-2b; SCH 54031) (Biological)
Co-infected with HCV and HIV
Participants co-infected with HCV and Human Immunodeficiency Virus (HIV).
干预措施: Rebetol (ribavirin; SCH 18908) (Drug)
结局指标
主要结局
Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment
时间窗: Assessed at Treatment Week 4
Rapid virologic response (RVR) was defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) negative after 4 weeks of treatment.
次要结局
- Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR(Treatment Week 48 and Treatment Week 72)
- Number of Participants Who Achieved Sustained Virologic Response (SVR)(Assessed at 24 weeks post-treatment)
- Number of Participants With RVR Who Also Achieved SVR(Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR))
- Assessment of Baseline Characteristics in Participants With SVR(24 Weeks post-treatment)