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Last Updated: November 22, 2019

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CLINICAL TRIALS PROFILE FOR ELBASVIR; GRAZOPREVIR

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All Clinical Trials for Elbasvir; Grazoprevir

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01717326 A Study of the Combination Regimen Grazoprevir (MK-5172) and Elbasvir (MK-8742) ± Ribavirin in Participants With Chronic Hepatitis C (MK-5172-035) Completed Merck Sharp & Dohme Corp. Phase 2 2013-02-01 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.
NCT01932762 Efficacy and Safety of Combination Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin (RBV) in Genotype 2 Hepatitis C Infection (MK-5172-047) Completed Merck Sharp & Dohme Corp. Phase 2 2013-10-01 This is a multi-site, open-label trial evaluating the safety and efficacy of 100 mg of grazoprevir (MK-5172) used in combination with or without 50 mg of elbasvir (MK-8742) and/or ribavirin (RBV) in treating non-cirrhotic treatment-naïve participants with chronic genotype (GT) 2, 4, 5, and 6 hepatitis C infection. In Part A there is no randomization or stratification; all GT2 participants will be assigned to arm A1. In Part B, all GT2 participants will be assigned to Arm B1 and all participants with GT4, GT5 and GT6 will be randomized in a 1:1 ratio to either Arm 3 or Arm 4 with stratification by genotype.
NCT01937975 The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050) Completed Merck Sharp & Dohme Corp. Phase 1 2013-09-01 Grazoprevir (MK-5172) and Elbasvir (MK-8742) were studied as the principal components of combination oral therapy for hepatitis C virus (HCV). The study examined the pharmacokinetic (PK) profiles of Grazoprevir and Elbasvir following 10 days of dosing in participants with end stage renal disease (ESRD) on hemodialysis (HD) or participants with severe renal impairment. Both groups were compared to healthy matched controls.
NCT02092350 Safety and Efficacy of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Participants With Chronic Hepatitis C and Chronic Kidney Disease (MK-5172-052) Completed Merck Sharp & Dohme Corp. Phase 2/Phase 3 2014-03-01 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%.
NCT02105454 Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin in Participants With Chronic Hepatitis C Who Failed Prior Direct-Acting Antiviral Therapy (MK-5172-048) Completed Merck Sharp & Dohme Corp. Phase 2 2014-05-01 In this study, participants with hepatitis C virus (HCV) genotype 1 (GT1) who failed prior direct-acting antiviral (DAA) therapy will receive Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin (RBV) to evaluate sustained virologic response (SVR) using this drug combination.
NCT02105467 Study of Efficacy and Safety of Grazoprevir (MK-5172)/Elbasvir (MK-8742) Combination Regimen for Treatment-Naïve Participants With Chronic Hepatitis C Virus Genotypes 1, 4, and 6 (MK-5172-060) Completed Merck Sharp & Dohme Corp. Phase 3 2014-06-01 This was an efficacy and safety study of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) in treatment-naive participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infection. Participants were randomly assigned (3:1 ratio) to immediate treatment or deferred treatment (placebo control). The primary efficacy hypothesis was that the proportion of participants receiving combination therapy in the Immediate Treatment Arm who achieve sustained viral response at 12 weeks after the end of study treatment (SVR12) is superior to 73%.
NCT02105662 An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus in Participants Who Are Co-Infected With Human Immunodeficiency Virus:C-EDGE CO-INFXN (MK-5172-061) Completed Merck Sharp & Dohme Corp. Phase 3 2014-06-01 The purpose of this study is to assess the efficacy and safety of grazoprevir (MK-5172) 100 mg in combination with elbasvir (MK-8742) 50 mg in the treatment of chronic hepatitis C virus (HCV) in participants who are co-infected with human immunodeficiency virus (HIV). The primary hypothesis is that the percentage of participants who receive grazoprevir + elbasvir and achieve Sustained Virologic Response after 12 weeks of therapy (SVR12) will be greater than 70%.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Elbasvir; Grazoprevir

Condition Name

Condition Name for Elbasvir; Grazoprevir
Intervention Trials
Hepatitis C 31
Chronic Hepatitis C 6
HIV 3
Hepatitis C, Chronic 3
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Condition MeSH

Condition MeSH for Elbasvir; Grazoprevir
Intervention Trials
Hepatitis C 52
Hepatitis 42
Hepatitis C, Chronic 18
Hepatitis A 18
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Clinical Trial Locations for Elbasvir; Grazoprevir

Trials by Country

Trials by Country for Elbasvir; Grazoprevir
Location Trials
United States 8
United Kingdom 3
Netherlands 3
Taiwan 3
Australia 2
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Trials by US State

Trials by US State for Elbasvir; Grazoprevir
Location Trials
Pennsylvania 3
Massachusetts 2
California 1
Texas 1
Maryland 1
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Clinical Trial Progress for Elbasvir; Grazoprevir

Clinical Trial Phase

Clinical Trial Phase for Elbasvir; Grazoprevir
Clinical Trial Phase Trials
Phase 4 19
Phase 3 18
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Elbasvir; Grazoprevir
Clinical Trial Phase Trials
Not yet recruiting 25
Completed 16
Recruiting 8
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Clinical Trial Sponsors for Elbasvir; Grazoprevir

Sponsor Name

Sponsor Name for Elbasvir; Grazoprevir
Sponsor Trials
Merck Sharp & Dohme Corp. 38
University of Pennsylvania 3
Kirby Institute 2
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Sponsor Type

Sponsor Type for Elbasvir; Grazoprevir
Sponsor Trials
Other 41
Industry 39
U.S. Fed 1
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