Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Chronic Hepatitis C Participants With Child-Pugh (CP)-B Hepatic Insufficiency

Protocol: 
MK-5172-059
Phase: 
II

Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Chronic Hepatitis C Participants With Child-Pugh (CP)-B Hepatic Insufficiency

A Phase II/III Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 ± Ribavirin (RBV) in Subjects with Chronic Hepatitis C Virus Infection with Advanced Cirrhosis and Child-Pugh (CP)-B Hepatic Insufficiency

This study is being done to evaluate the efficacy and safety of the drug combination grazoprevir (MK-5172) + elbasvir (MK-8742) in participants with chronic hepatitis C (CHC) genotype (GT) 1, 4, or 6 infection and who have cirrhosis and Child-Pugh (CP) score 7-9 moderate hepatic insufficiency. The primary hypothesis is that the percentage of HCV-infected participants with hepatic insufficiency (the CP-B population) achieving sustained viral response (SVR) 12 weeks after the end of all treatment (SVR12) will be greater than 60%. Additionally, ten non-cirrhotic HCV-infected GT1 participants will also be given grazoprevir + elbasvir at the beginning of the study; this will be done for the purpose of collecting plasma pharmacokinetic data in HCV GT1-infected participants who do not have hepatic insufficiency.

Trial Website: https://clinicaltrials.gov/show/NCT02115321

Are you Eligible? (Inclusion Criteria)

Inclusion criteria:

  • Has documented chronic HCV GT1 infection (for Arm 4 participants may have GT4 or GT6 infection) with no evidence of non-typable or mixed genotype infection
  • Has clinical evidence of hepatic cirrhosis with a score on the Child-Pugh scale from 7 to 9 and not anticipated to receive a liver transplant within the next 36 weeks (for Arm 1, Arm 3, and Arm 4)
  • Has no evidence of cirrhosis (only for Arm 2 )
  • Agrees to remain truly abstinent or use (or have their partner use) an acceptable method of birth control from at least 2 weeks prior to Day 1 and continue until at least 14 days after last dose of study drug, or longer if dictated by local regulations

Exclusion criteria:

  • Is co-infected with hepatitis B virus or human immunodeficiency virus (HIV)
  • Has previously received direct-acting antiviral therapy for HCV
  • 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 under evaluation for other active or suspected malignancy
  • Has cirrhosis and liver imaging results within 4 weeks prior to screening showing evidence of hepatocellular carcinoma (HCC), or is under evaluation for HCC
  • 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
  • Has clinically-relevant drug or alcohol abuse within 12 months of screening
  • Is pregnant or breast-feeding, or expecting to conceive or donate eggs or sperm from at least 2 weeks prior to Day 1 and continue throughout treatment and follow up, or longer if dictated by local regulations
  • Has received organ transplants (including hematopoietic stem cell transplants) other than cornea and hair
  • Has poor venous access
  • Has a history of gastric surgery (e.g., stapling, bypass) or history of malabsorption disorders (e.g., celiac sprue disease)
  • Requires, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
  • 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

Specialty Area(s)

Trial Location

NYP/Columbia
New York, NY 10032
United States