EUCTR2014-000672-25-EE进行中（未招募）不适用
A Phase II/III Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects with Chronic Hepatitis C Virus Infection with Advanced Cirrhosis and Child-Pugh (CP)-B Hepatic Insufficiency. - MK-5172 + MK-8742 in HCV-infected subjects with hepatic insufficiency (CP-B)
Merck Sharp & Dohme Corp., a subsidary of Merck & Co.0 个研究点目标入组 103 人开始时间: 2014年12月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 103
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
- •1. be =18 years of age on day of signing informed consent.
- •2. have HCV RNA (= 10,000 IU/mL in peripheral blood) at the time of screening.
- •3. have documented chronic HCV GT1 infection (Part C subjects may have GT4 or GT6
- •infection), with no evidence of non-typeable or mixed genotype) infection:
- •- Positive for anti-HCV antibody, HCV RNA, or any of the above HCV genotypes at
- •least 6 months before screening, or
- •- Positive for anti-HCV antibody or HCV RNA at the time of screening with a liver biopsy
- •consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of CHC disease, such as the presence of fibrosis)
- •4. have evidence of hepatic cirrhosis with a score on the Child-Pugh scale from 7 to 9 (moderate hepatic insufficiency) at the time of screening and not anticipated to receive a
- •liver transplant within the next 36 weeks (for Arm 1 in Part A, Arm 3 in Part B and Arm 4 in Part C).
- •5. have no evidence of cirrhosis based on the following (only for Arm 2 in Part A):
- •- Liver biopsy performed within 24 months of Day 1 of this study showing absence of cirrhosis
- •- Fibroscan performed within 12 months of Day 1 of this study with a result of =9.5 kPa
- •- A FibroSure® (Fibrotest®) score of =0.48 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) of =1 during Screening
- •*Fibroscan cut-off of 12.5 kPa has a positive predictive value of 90% and a sensitivity of 65% for =F3. Based on box and whisker plot of interquartile distribution >12.5 kPa will exclude the majority of subjects with metavir F3 fibrosis.
- •In the absence of a definitive diagnosis of presence or absence of cirrhosis by the above criteria, a liver biopsy is required. Liver biopsy results supersede the results obtained by Fibroscan or FibroSure®
- •6. agree to the following:
- •- The subject is a female who is not of reproductive potential, defined as a female who
- •either: (1) is postmenopausal (defined as at least 12 months with no menses in women
- •=45 years of age); (2) has had a hysterectomy and/or bilateral oophorectomy, bilateral
- •salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening;
- •OR (3) has a congenital or acquired condition that prevents childbearing.
- •- The subject is a female who is of reproductive potential and agrees to avoid becoming
- •pregnant while receiving study drug and for 14 days after the last dose of study drug by complying with one of the following: (1) practice abstinence from heterosexual activity OR (2) use (or have her partner use) acceptable contraception during heterosexual activity. Acceptable methods of contraception are:
- •Single method (one of the following is acceptable):
- •- intrauterine device (IUD)
- •- vasectomy of a female subject’s male partner
- •- contraceptive rod implanted into the skin
- •Combination method (requires use of two of the following):
- •- diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide)
- •-cervical cap with spermicide (nulliparous women only)
- •- contraceptive sponge (nulliparous women only)
- •- male condom or female condom (cannot be used together)
- •- hormonal contraceptive: oral contraceptive pill (estrogen/progestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection
- •7. understand the study procedures, alternative treatments available, risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
排除标准
- •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. is co-infected with hepatitis B virus (e.g. HBs Ag positive) or HIV.
- •3. has previously received direct-acting antiviral therapy for HCV.
- •4. has a history of malignancy =5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or is under evaluation for other active or suspected malignancy.
- •5. has cirrhosis and liver imaging within 4 weeks prior to screening showing evidence of hepatocellular carcinoma (HCC), or is under evaluation for HCC.
- •Note: If liver imaging within 4 weeks of screening is not available, imaging is required during screening.
- •6. is taking or plans to take any of the prohibited medications listed in Section 5 of this protocol or taking herbal supplements, including but not limited, to St. John’s Wort (Hypericum perforatum) within 2 weeks of Day 1.
- •7. 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 such study during the course of this study.
- •8. has a clinically-relevant drug or alcohol abuse within 12 months of screening.
- •9. is a female and is pregnant or breast-feeding, or expecting to conceive or donate eggs
- •from Day 1 throughout treatment, and 14 days after the last dose of study medication, or
- •longer if dictated by local regulations.
- •10. has any of the following conditions:
- •Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair.
- •Poor venous access that precludes routine peripheral blood sampling required for this trial.
- •Subject with a history of gastric surgery (e.g., stapling, bypass) or subject with a history of malabsorption disorders (e.g., celiac sprue disease).
- •Any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial.
- •11. has any condition or prestudy laboratory abnormality, or history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs to the subject.
- •12. has a life-threatening SAE during the screening period.
- •13. has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis.
- •NOTE: Subjects with history of acute non-HCV-related hepatitis, which resolved > 6 months before study entry, can be enrolled.
- •14. has exclusionary laboratory values as listed below:
- •Note: If any of the laboratory exclusion criteria below are met, the site may have the abnormal value retested one time.
- •Exclusionary Laboratory Values
- •Laboratory Assessment Cirrhotic (CP-B)
- •Hemoglobin <9.5 g/dL for both male and female subjects
- •Creatinine Clearance <30 mL/min
- •Platelets < 30 x 103/µL
- •Serum Albumin < 2.2 g/dL
- •Total Bilirubin > 3.0 mg/dL
- •HbA1c >10%
- •ALT >5 x ULN
- •AST >5 x ULN
研究者
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