EUCTR2013-002169-21-GB进行中（未招募）不适用
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of a Combination Regimen of MK-5172 with/without MK-8742 and/or Ribavirin (RBV) in Treatment-naive Subjects with Chronic Hepatitis C Genotype 2, 4, 5 and 6 Infection. - MK-5172+/-MK-8742+/-RBV in Treating Subjects With Genotype 2,4,5 and 6 Chronic Hep C Infection
适应症
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
- 100
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:
- •The following applies to both Part A and Part B (unless specified otherwise)
- •1. be at least 18 years of age on day of signing informed consent.
- •2. have a body weight above 50 kg (111 lbs) and below 125 kg (275 lbs).
- •3. For Part A only: have Chronic Hepatitis C Virus infection; specifically genotype 2. The amino acid variant at position 31 in the NS5A region must be documented prior to enrollment of the study.
- •For Part B only: have chronic Hepatitis C virus GT2 or GT4, or GT5 or GT6 infection.
- •- Positive for antiHCV antibody, HCV RNA or an HCV genotype at least 6 months before screening and positive for HCV RNA more than 10,000 IU/mL in blood at the time of screening.
- •- Absences of ascites, bleeding esophageal varices, hepatic encephalopathy or other signs or symptoms of advanced liver disease or cirrhosis.
- •4. absence of cirrhosis, defined as any one of the following:
- •- Liver biopsy performed within 2 years of day 1 of this study showing absence of cirrhosis.
- •- Fibroscan (in countries where locally approved) performed within 12 months of day 1 of this study with a result of <12.5 kPa
- •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 2 weeks prior to day 1 and continue until at least 7 months after last dose of study drug for male subject with female sexual partner who is of childbearing potential).
- •6. understand the study procedures, alternative treatments available, risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
- •7. provide written informed consent for the trial. The subject may also provide consent/assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 29
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •The subject must be excluded from participating in the trial if the subject:
- •The following criteria apply to both Part A and Part B (unless specified otherwise)
- •1. is under the age of legal consent, is mentally or legally incapacitated, has significant emotional problems at the time of pre-study screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures.
- •2. For Part A: has non genotype 2 Hepatitis C Virus infection, including a mixed GT infection or a non-typeable genotype.
- •For Part B: has HCV infection with a genotype other than GT2, GT4, GT5 or GT6, including a mixed GT infection or infection with nontypeable genotype.
- •3. is not treatment naïve (has previously received treatment for Hepatitis C).
- •4. proven to be coinfected with hepatitis B or HIV.
- •5. is currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another study. Collection of additional blood, urine, or tissue samples or additional data, beyond that specified in this protocol, is prohibited (other than that related to subject’s medical care).
- •6. has a clinical diagnosis of substance abuse.
- •7. has evidence of active or suspected malignancy (cancer), or a history of malignancy, within the last 5 years. Subjects under evaluation for malignancy are not eligible.
- •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; or male subject is planning to impregnate or provide sperm donation or has a female sexual partner of childbearing potential and is unwilling to commit to using two methods of birth control throughout treatment and after the completion of all treatment .
- •9. is a male whose female partner(s) is pregnant.
- •10. has any other condition which, in the opinion of the principal investigator or study physician, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study.
- •11. is a member or a family member of the investigational study staff or sponsor staff directly involved with this study.
- •12. has evidence or history of chronic hepatitis not caused by Hepatitis C Virus.
- •13. For subjects diagnosed with diabetes mellitus, documented HbA1C > 8.5% to exclude uncontrolled diabetes.
- •14. Has exclusionary laboratory values:
- •Laboratory Assessment Non cirrhotic
- •hemoglobin < LLN (lower limit of normal) of laboratory reference range
- •neutrophils <1.5 x 103/µL (<1.2 x 103/µL for Blacks)
- •platelets <125 x 103/µL
- •direct bilirubin>1.5 x ULN
- •Total Bilirubin >1.6 mg/dL unless history of Gilbert's disease. (If Gilbert’s disease is the proposed etiology, this must be documented in the subject’s chart)
- •Serum Albumin < 3.5 g/dL (lower limit of normal) of laboratory reference range
- •creatinine clearance<50 mL/min
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