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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR ELBASVIR; GRAZOPREVIR

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Clinical Trials for Elbasvir; Grazoprevir

Trial ID Title Status Sponsor Phase 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 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 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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Elbasvir; Grazoprevir

Condition Name

Condition Name for Elbasvir; Grazoprevir
Intervention Trials
Hepatitis C 27
Chronic Hepatitis C 5
HIV 3
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Condition MeSH

Condition MeSH for Elbasvir; Grazoprevir
Intervention Trials
Hepatitis C 45
Hepatitis 39
Hepatitis A 17
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Clinical Trial Locations for Elbasvir; Grazoprevir

Trials by Country

Trials by Country for Elbasvir; Grazoprevir
Location Trials
United States 8
Taiwan 2
Netherlands 2
France 2
United Kingdom 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 14
Phase 3 17
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 21
Completed 14
Recruiting 7
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Clinical Trial Sponsors for Elbasvir; Grazoprevir

Sponsor Name

Sponsor Name for Elbasvir; Grazoprevir
Sponsor Trials
Merck Sharp & Dohme Corp. 34
University of Pennsylvania 3
Fundacion Clinic per a la Recerca Biomédica 2
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Sponsor Type

Sponsor Type for Elbasvir; Grazoprevir
Sponsor Trials
Industry 35
Other 32
U.S. Fed 1
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Cipla
Boehringer Ingelheim
McKinsey
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Express Scripts

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