A Phase III, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 versus Sofosbuvir/Pegylated Interferon/Ribavirin (PR) in Treatment-Naïve and PR Prior Treatment Failure Subjects with Chronic HCV GT1, 4 or 6 Infection - MK-5172/MK-8742 vs Sofosbuvir/PR in HCV GT1, 4 or 6 Infection

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites256 target enrollmentDecember 16, 2014

ConditionsHepatitis C MedDRA version: 17.1Level: LLTClassification code 10019751Term: Hepatitis C virusSystem Organ Class: 100000004848 Therapeutic area: Diseases [C] - Virus Diseases [C02]

DrugsRebetol PegIntron Sovaldi

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hepatitis C
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 256
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 16, 2014

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Be ?18 years of age on day of signing informed consent
•2\. Weigh ? 40 kg and ?125 kg
•3\. Have HCV RNA ? 10,000 IU/mL at the time of screening
•4\. Have documented chronic HCV GT 1, 4 or 6 (with no evidence of non\-typeable or mixed genotype) infection:
•? Positive for anti\-HCV antibody, HCV RNA, or HCV GT 1, 4 or 6 at least 6 months before screening (HCV RNA and HCV genotype must be confirmed by screening lab results), 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)
•5\. Have liver disease staging assessment as follows:
•Cirrhosis is defined as any one of the following \[29]\[30]:
•? A liver biopsy performed prior to Day 1 of this trial showing cirrhosis (F4\)
•? Fibroscan performed within 12 calendar months of Day 1 of this trial showing cirrhosis with result \>12\.5 kPa \[30]\*

Exclusion Criteria

•1\. Is under the age of legal consent, is mentally or legally incapacitated, has significant emotional problems at the time of pre\-trial screening visit or expected during the conduct of the trial or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the trial procedures.
•2\. Subject is not, in the opinion of the investigator, an appropriate candidate for only 12 weeks of PR\-based therapy.
•NOTE: All subjects in this trial will only receive 12 weeks of treatment. Based on the SOF EU label, investigators should consider the following and decide if a subject is appropriate for enrollment. ?Consideration should be given to potentially extending the duration of therapy beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon\-based therapies (e.g. advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype, prior null response to peg interferon alfa and ribavirin therapy)? \[31].
•3\. Has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease. For cirrhotics, subjects that are Child\-Pugh Class B or C or who have a Pugh\-Turcotte (CPT) score \>6, must be excluded.
•NOTE: To calculate the Child\-Pugh score, refer to the following website: http://www.mdcalc.com/child\-pugh\-score\-for\-cirrhosis\-mortality.
•4\. Is co\-infected with hepatitis B virus (e.g., HBsAg positive) or HIV.
•5\. 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.
•6\. Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC.
•NOTE: If liver imaging within 6 months of Day 1 is not available, imaging is required during screening.
•7\. Is taking or plans to take any of the prohibited medications listed in Section 5\.5\.1 of this protocol or taking herbal supplements, including but not limited to: