Safety and Efficacy of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Participants With Chronic Hepatitis C and Chronic Kidney Disease (MK-5172-052)

Last updated: August 23, 2018
Sponsor: Merck Sharp & Dohme Corp.
Overall Status: Completed

Phase

2/3

Condition

Hepatitis

Hiv

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT02092350
5172-052
2013-003858-25
  • Ages > 18
  • All Genders

Study Summary

This study will evaluate the safety and efficacy of combination treatment with grazoprevir (MK-5172) + elbasvir (MK-8742) for cirrhotic and non-cirrhotic participants with chronic Genotype 1 (GT1) hepatitis C virus (HCV) infection and chronic kidney disease (CKD). The primary study hypothesis is that the proportion of HCV GT1-infected CKD participants within the Immediate Treatment and Intensive Pharmacokinetics (PK) groups achieving a sustained viral response 12 weeks after the end of all study treatment (SVR12) will be >45%.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented chronic (at least 6 months) HCV GT 1 infection (with no evidence of mixedgenotypes or genotype that cannot be assigned a type)

  • Evidence or no evidence of liver cirrhosis based on one of the following:

  • Liver biopsy performed within 24 months of Day 1 (if participant is cirrhotic thenthere is no time restriction on biopsy)

  • Fibroscan performed within 12 months of Day 1 of this study

  • Fibrosure™ (Fibrotest™) plus aspartate aminotransferase to platelet Ratio Index [APRI]obtained during the screening period)

  • Has HCV status that is one of the following:

  • Treatment naïve

  • Prior interferon or pegylated interferon with or without ribavarin failures (nullresponder, partial responder, or relapser)

  • Intolerant to prior interferon or pegylated intereferon with or without ribavarinregimen

  • Chronic kidney disease (defined as glomerular filtration rate [eGFR] <=29)non-dialysis dependent or on hemodialysis for at least 3 months, including individualsawaiting kidney transplant and those with failed kidney transplants but no longer onimmunosuppressant therapy)

  • Female participant of reproductive potential must agree to remain abstinent or use (orhave their partner use) 2 acceptable methods of contraception from at least 2 weeksprior to Day 1 through 14 days after the last dose of study drugs, or longer ifdictated by local regulations

Exclusion

Exclusion Criteria:

  • Evidence of decompensated liver disease

  • On peritoneal dialysis for management of kidney disease

  • Co-infection with hepatitis B virus or human immunodeficiency virus (HIV)

  • History of malignancy <=5 years prior to signing informed consent

  • Clinical diagnosis of substance abuse

  • Pregnant, breast-feeding, expecting to conceive or donate eggs, or donate sperm fromDay 1 through 14 days after the last study dose, or longer if dictated by localregulations

  • Organ transplant (including hematopoietic stem cell transplant) other than kidney,cornea, and hair

  • Conditions requiring, or likely to require, chronic systemic administration ofcorticosteroids during the course of the trial

  • Uncontrolled or poorly controlled hypertension

  • Significant cardiovascular disorder (e.g. myocardial infarction or unstable angina) orcardiovascular procedure within 3 months prior to signing informed consent

  • New or worsening signs or symptoms of congestive heart failure within 3 months ofsigning informed consent

  • Severe active peripheral vascular disease

  • Recent (within 3 months prior to signing informed consent) episode or recurrence ofstroke, transient ischemic attack (TIA) or neurological disorder, including but notlimited to seizures

  • Evidence or history of chronic hepatitis not caused by HCV

Study Design

Total Participants: 237
Study Start date:
March 17, 2014
Estimated Completion Date:
September 02, 2015

Connect with a study center

  • Merck Sharp & Dohme (Argentina) Inc.

    Buenos Aires,
    Argentina

    Site Not Available

  • Merck Sharp & Dohme

    North Ryde,
    Australia

    Site Not Available

  • Merck Canada

    Kirkland, Quebec H9H 3L1
    Canada

    Site Not Available

  • Merck Sharp & Dohme OU

    Tallinn,
    Estonia

    Site Not Available

  • MSD France

    Paris,
    France

    Site Not Available

  • Merck Sharp & Dohme Co. Ltd.

    Hod Hasharon,
    Israel

    Site Not Available

  • MSD Korea LTD

    Seoul,
    Korea, Republic of

    Site Not Available

  • UAB "Merck Sharp & Dohme"

    Vilnius,
    Lithuania

    Site Not Available

  • Merck Sharp & Dohme BV

    Haarlem,
    Netherlands

    Site Not Available

  • Merck Sharp and Dohme de Espana S.A.

    Madrid,
    Spain

    Site Not Available

  • MSD

    Sollentuna,
    Sweden

    Site Not Available

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