Safety and Efficacy of Boceprevir in Combination With Peginterferon Plus Ribavirin for Treatment of Asia Pacific Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Pegylated Interferon Plus Ribavirin (Protocol No. P07063)

Merck Sharp and Dohme a subsidiary of Merck Co inc0 个研究点目标入组 390 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Prevoiusly documented CHC genotype 1 infection. Other or mixed genotypes are not eligible
•- Liver biopsy with histology consistent with CHC and no other etiology
•- Participants with cirrhosis must have an ultrasound/imaging study within 6 months of screening (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma
•Failed previous treatment (of at least 12 weeks) with pegylated interferon (alfa-2a or alfa-2b) plus RBV
•- Weight between 40 kg and 125 kg, inclusive
•- Of local ancestral descent
•- Sexually active males and females of child bearing potential must agree to use a medically accepted method of contraception

•- Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus
•- Required discontinuation of previous interferon or RBV regimen for an adverse event considered to be possibly or probably related to RBV and/or interferon
•- Treatment with RBV within 90 days and any interferon-alpha within 1 month before screening
•- Treatment for hepatitis C with any investigational medication or prior treatment with herbal remedies with known hepatotoxicity
•- Treatment with any investigational drug or participation in any interventional clinical trial within 30 days of the screening visit
•- Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
•- Diabetes and/or hypertension with clinically significant ocular examination findings
•- Any condition the could interfere with participation in and completion of the trial
•- Evidence of active or suspected malignancy, or history of malignancy within the last 5 years (except adequately treatment carcinoma in situ and basal cell carcinoma of the skin)
•- Pregnant or breast-feeding

发起方

Merck Sharp and Dohme a subsidiary of Merck Co inc