PREDICT - Prospective Observational Study Of A Cohort Of Naïve Patients With Chronic Hepatitis C Infected With Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) And Treated With Peg-Intron 1.5 ug/Kg/Week Plus Rebetol 800-1200 mg/Day Who Achieved A Negative HCV-RNA At Week 4 and at Week 24
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 496
- 主要终点
- Number of HCV LVL G1 Participants Who Relapsed
研究概览
简要总结
To determine the relapse rate at 24 weeks follow up in Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) patients treated for 24 weeks with Peg Intron and Rebetol who are Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) negative at treatment week 4 and week 24. To determine the proportion of patients (%) with sustained virological response at 24 weeks post follow up treatment.
详细描述
Approximately 500 patients from about 100 sites to be identified as HCV LVL G1 patients
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to participate
- •18 years or older, either gender, any race
- •Must have Hepatitic C Virus Low Viral Load [LCV LVL] (positive, but <600,000 IU/mL on the assay used by the individual study site. Only Hepatitis C Virus-Ribonucleic acid/quantitative polymerase chain reaction [HCV-RNA/qPCR] assays with results in IU/ml are acceptable) AND been diagnosed with Genotype 1
- •Subject considered suitable for treatment per local label
- •Investigator considers suitable and subject consents to be treated
排除标准
- •Does not show negative polymerase chain reaction [PCR] at week 4
- •Pregnant women or those who plan to become pregnant or sexual partners of women who plan to become pregnant
- •Subject does not qualify based on contra-indication, special warning, special population, and/or pregnancy & lactation section of the Summary of Product Characteristics [SmPC]
研究组 & 干预措施
PegIntron plus Rebetol
Those with chronic Hepatitis C infected with HCV LVL G1
干预措施: PegIntron (Drug)
PegIntron plus Rebetol
Those with chronic Hepatitis C infected with HCV LVL G1
干预措施: Rebetol (Drug)
结局指标
主要结局
Number of HCV LVL G1 Participants Who Relapsed
时间窗: Week 24 of follow-up
Relapse was defined as undetectable Hepatitis C virus-ribonucleic acid (HCV-RNA) at End of Treatment, but detectable HCV-RNA at Follow-up Week 24.
次要结局
未报告次要终点