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 Copr., a subsidary of Merck & Co.0 sites40 target enrollmentNovember 27, 2014

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Merck Sharp & Dohme Copr., a subsidary of Merck & Co.
Enrollment: 40
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 27, 2014

End Date

September 9, 2015

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Merck Sharp & Dohme Copr., a subsidary of Merck & Co.

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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.