EUCTR2012-003340-72-ES进行中（未招募）不适用
A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of MK-5172 in Combination with Ribavirin (RBV) in Subjects with Chronic Hepatitis C Virus Infection - MK-5172 + RBV in GT1 Treatment Naive Patients Pilot Study
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •In order to be eligible for participation in this trial, the subject must:
- •1. be > or = to 18 years of age on day of signing informed consent.
- •2. have a body weight >50 kg (111 lbs) and ? 125 kg (275 lbs).
- •3. have chronic, compensated HCV GT 1a infection for Part A and GT1 (1a or 1b) for Part B as defined by:
- •-Positive serology for HCV with HCV RNA levels > or = to 10,000 IU/mL in peripheral blood at screening, and
- •-Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease, or cirrhosis
- •4. have had no evidence of cirrhosis and/or hepatocellular carcinoma. This can be confirmed either by liver biopsy or by non-invasive methods such as fibrotest or fibroscan in countries where biopsy is not the standard method of diagnosis.
- •5. agree to use two acceptable methods of birth control from at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations (for female subject who is of childbearing potential or male subject with female sexual partner who is of childbearing potential).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •Subject will be excluded from participating in the trial if the subject:
- •1) has a non-GT 1 HCV infection, including a mixed GT infection (with a non-GT 1) or a non-typeable genotype.
- •2) is NOT treatment naïve, i.e. subject has had previous treatment with any interferon, ribavirin, approved or experimental direct acting antiviral(s), or other investigational therapies for HCV.
- •3) As determined by documented records, subject is HIV positive or known to be coinfected with hepatitis B virus (HBsAg positive).
- •4) has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC.
- •5) has pre-existing psychiatric condition(s)
- •6) has any known medical condition that could interfere with the subjects participation in and completion of the trial
- •7) has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years
- •8) (female) is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential and unwilling to commit to two methods of birth control throughout treatment and after the completion of all treatment
- •9) is a male whose female partner(s) are pregnant
- •10) has exclusionary laboratory values as listed in the protocol
- •i) Hemoglobin <12 g/dL for females and <13 g/dL for males.
- •ii) Neutrophils <1.5 x 103/uL (<1.2 x 103/uL for Blacks).
- •iii) Platelets <150 x 103/uL
- •iv) Direct bilirubin >1.5 x ULN (upper limit of normal) of the laboratory reference range
- •v) Serum glucose:
- •- For subjects not previously diagnosed with diabetes mellitus, > or = to ULN mg/dL (fasting) unless HbA1c < or = to 7%.
- •- For subjects previously diagnosed with diabetes mellitus, HbA1c > 8.5%.
- •vi) PT/PTT values > 10% above laboratory reference range
- •vii) Anti-nuclear antibodies (ANA) > 1:320
- •viii) ALT > 350IU/L
- •ix) AST > 350 IU/L
研究者
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