A Study of the Combination Regimen Grazoprevir (MK-5172) and Elbasvir (MK-8742) ± Ribavirin in Participants With Chronic Hepatitis C (MK-5172-035)

• Status: Completed
• Trial end date: 2015-05-06
• Target enrollment: 0
• Participant gender: All

Summary

This is a study of the safety and efficacy of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) ± ribavirin (RBV). The primary efficacy endpoint will be Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) in each of the treatment arms.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Grazoprevir; Ribavirin

Criteria

Inclusion criteria:

All participants

• CHC genotype 1 (GT1) virus infection (Parts A, B, and C) or GT3 virus infection (Part D)

• Female participants of childbearing potential or male participant with female partners of childbearing potential, must use two acceptable methods of birth control from ≥2 weeks prior to Day 1 until ≥6 months after last dose of study drug, or longer if dictated by local regulations

Part A - Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease, or cirrhosis - No evidence of advanced fibrosis, cirrhosis and/or hepatocellular carcinoma by biopsy or noninvasive testing (FibroScan and/or FibroTest)

Parts B, C, and D

• Treatment naïve with or without cirrhosis, or

• Prior treatment failure to Peg-IFN/Ribavirin with or without cirrhosis, or

• Co-infected with human immunodeficiency virus (HIV) without cirrhosis

• Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease

• Liver disease staging assessment by liver biopsy or noninvasive testing (FibroScan and/or FibroTest)

Exclusion criteria:

All participants

• Non-GT1 HCV infection (Part A, Part B, and Part C) or a non-GT3 HCV infection (Part D) including a mixed GT infection (with a non-GT1 [Part A, Part B, and Part C] or non-GT3 [Part D]) or a non-typeable genotype

• Evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC

• Currently participating or 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 study

• Diabetic and/or hypertensive with clinically significant ocular examination findings

• History of depression associated with hospitalization for depression, electroconvulsive therapy, or resulting in prolonged absence from work and/or significant disruption of daily functions

• Suicidal or homicidal ideations and/or attempt, or history of severe psychiatric disorders

• Clinical diagnosis of substance abuse

• Current history of seizure disorder, stroke, or transient ischemic attack

• Immunologically mediated disease

• Chronic pulmonary disease

• Clinically significant cardiac abnormalities/dysfunction

• Active clinical gout within the last year

• Hemoglobinopathy or myelodysplastic syndromes

• History of organ transplants including hematopoietic stem cell transplants

• Poor venous access

• Indwelling venous catheter

• History of gastric surgery or malabsorption disorders

• Severe concurrent disease

• Evidence of active or suspected malignancy, or a history of malignancy, ≤5 years before

• Pregnant, lactating, expecting to conceive or donate eggs

• Male participant with pregnant female partner

• Member/family member of the investigational study or sponsor staff directly involved with this study

• Evidence or history of chronic hepatitis not caused by HCV

Part A

• Not treatment-naïve

• Documented to be HIV positive

• Taking or planning to take significant inducers or inhibitors of CYP3A4 substrates or herbal supplements 2 weeks prior to start of study medications

Parts B, C, and D

• Previously received any HCV direct-acting antivirals

• Requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial

• For participants diagnosed with diabetes mellitus, documented HbA1c >8.5%