MK-5172 in Combination with MK-8742 in subjects with HCV andChronic Kidney Disease
- Conditions
- Hepatitis CTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2013-003858-25-NL
- Lead Sponsor
- Merck Sharp & Dohme Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 237
1. Be =18 years of age on day of signing informed consent. 2. Have documented chronic (at least 6 months) HCV GT1 infection (with no evidence of non typable or mixed genotypes) : • Positive for anti-HCV antibody, HCV RNA, or an HCV genotype • HCV RNA (= 10,000 IU/mL in peripheral blood) 3.Subjects with or without cirrhosis may be enrolled into this study. All subjects must have one of the below liver disease staging assessments as follows: • Liver biopsy performed within 24 months of Day 1 (if subject is cirrhotic then there is no time restriction on biopsy) • Fibroscan performed within 12 months of Day 1 • A FibroSure® (Fibrotest®) and Aspartate Aminotransferase to Platelet Ratio Index (APRI) (APRI is automatically calculated by central laboratory) during Screening In the absence of a definitive diagnosis of presence or absence of cirrhosis by the above critieria, a liver biopsy is required. Liver biopsy results supersede the results obtained by Fibroscan or FibroSure®. 4. Have an HCV treatment status that is one of the following: Treatment naïve: Naive to all anti-HCV treatment Prior IFN or PEG-IFN + Ribavirin Treatment failures: Null responders, Partial responders, Relapsers. P/R Intolerant: Subjects were intolerant to a prior IFN or PEG-IFN ± Ribavirin regimen, Subjects discontinued treatment prematurely and were therefore unable to complete a full course of therapy because of drug-related toxicity. 5. Have Chronic Kidney Disease defined as: Subjects with GFR =29 who are non-dialysis dependent (NDD) or have been on hemodialysis (HD) for at least 3 months (including subjects awaiting kidney transplant and subjects with failed kidney transplants no longer on immunosuppressant therapy). 6. Agree (if subject is of reproductive potential) to remain truly abstinent or use (or have their partner use) 2 acceptable methods of birth control from at least 2 weeks prior to Day 1 and through 14 days after the last dose of study drugs, or longer if dictated by local regulations. If acceptable by local regulatory agencies, methods of birth control allowed in the study are: intrauterine device (IUD), diaphragm with spermicide, hormonal contraceptives (e.g., birth control pills, transdermal patch, or injectables), contraceptive sponge, female condom, male condom with spermicide or vasectomy. 7. A female subject who is not of reproductive potential is eligible without requiring the use of contraception. A female subjects who is not of reproductive potentials is defined as one who has either 1) reached natural menopause (defined as 12 months with no menses without an alternative medical cause), 2) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy, or 3) bilateral tubal ligation. 8. A male subject who is not of reproductive potential is eligible without requiring the use of contraception. A male subject who is not of reproductive potential is defined as: one who has undergone a successful vasectomy. A successful vasectomy is defined as: (1) microscopic documentation of azoospermia, or (2) a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post vasectomy. 9. understand the study procedures, alternative treatments available, risks involved with the study, and voluntarily agrees to participate by giving written informed consent. 10. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical
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. Evidence of decompensated liver disease manifested by the presence of or history of ascites, gastric or variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease. 3. Is on peritoneal dialysis for management of Kidney disease 4. In the opinion of the investigator the subject has a high likelihood of receiv ing a renal transplant during the study treatment period (up to 24 weeks from Day 1). 5. Is coinfected with hepatitis B virus (e.g. HBsAg positive) or HIV. 6. 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 has evidence of hepatocellular carcinoma (HCC) or is under evaluation for other active or suspected malignancy. 7. Is taking or plans to take any of the prohibited medications listed in Section 5 of this protocol within 2 weeks of Day 1. 8. 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. 9. has a clinical diagnosis of substance abuse of the following specified drugs within specified timeframes: • alcohol, intravenous drugs, inhalational (not including marijuana), psychotropics, narcotics, cocaine use, prescription or over -the-counter drugs: within 1 year of the screening visit or, if shorter is judged by the investigator to be capable of complying with study procedures, OR • history of marijuana use is deemed excessive by a physician investigator or is interfering with the subject's daily function. If subject's marijuana use is not deemed excessive and does not interfere with daily function, subject must be instructed to discontinue any current use of recreational marijuana prior to entry into trial and throughout the trial period. 9. has a clinical diagnosis of substance abuse of the following specified drugs within specified timeframes: • alcohol, intravenous drugs, inhalational (not including marijuana), psychotropics, narcotics, cocaine use, prescription or over -the-counter drugs: within 1 year of the screening visit or, if shorter is judged by the investigator to be capable of complying with study procedures, OR • history of marijuana use is deemed excessive by a physician investigator or is interfering with the subject's daily function. If subject's marijuana use is not deemed excessive and does not interfere with daily function, subject must be instructed to discontinue any current use of recreational marijuana prior to entry into trial and throughout the trial period. 10. Female subject who is pregnant or breast-feeding, or expecting to conceive or donate eggs from Day 1 and through 14 days after the last dose of study drugs, or longer if dictated by local regulations or male subject who is expecting to donate sperm from Day 1 and through 14 days after the last dose of study drugs, or longer if dictated by local regulations.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method