MK-5172 + MK-8742 in HCV-infected subjects with hepatic insufficiency (CP-B)
- Conditions
- Hepatitis CMedDRA version: 17.1 Level: LLT Classification code 10019751 Term: Hepatitis C virus System Organ Class: 100000004848Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-000672-25-NL
- Lead Sponsor
- Merck Sharp & Dohme Copr., a subsidary of Merck & Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
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. 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 continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations.
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 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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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. Only silymarin (Milk Thistle, Silybum marianum) is permitted during the trial.
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 at least 2 weeks prior to Day 1 and continue throughout treatment and follow up, or longer if dictated by local regulations, or male subject who is expecting to donate sperm from at least 2 weeks prior to Day 1 and continue throughout treatment and follow up, 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 st
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