35 completed, 6 unknown, 3 withdrawn, 1 terminated. 16 Phase 3, 12 Phase 2, 11 Phase 4, 3 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 16 | Completed 12, Unknown 3, Withdrawn 1 |
| Phase 2 | 12 | Completed 12 |
| Phase 4 | 11 | Completed 8, Withdrawn 2, Terminated 1 |
| Phase 1 | 3 | Completed 3 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Clinical Trial to eLiminate HCV-infection in Treatment-naïve, Renally Impaired EgyptiAn Patients on Renal Dialysis, With Chronic Hepatitis C Genotype 4 Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER] - Hepatitis C Virus Infection, Response to Therapy of | Phase 4 | Withdrawn | University of Maryland, Baltimore | 2019-12-01 | 2020-04-20 | |
| Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier] - Hepatitis C, Hemodialysis | Phase 4 | Completed | University of Pennsylvania | 6 | 2019-09-22 | 2021-12-15 |
| Zepatier in Patients with Substance Use Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER] - Hepatitis C, Hiv | Completed | University of Illinois at Chicago | 25 | 2019-09-20 | 2025-01-28 | |
| Effectiveness and Safety of Direct-Acting Antiviral Agents for the Treatment of Chronic Hepatitis C Direct-acting antiviral agents - Hepatitis C, Chronic | Unknown | Qing XIe | 300 | 2019-03-06 | 2021-07-07 | |
| Grazoprevir/Elbasvir for Genotype 1b Chronic Hepatitis C After Liver or Kidney Transplantation grazoprevir 100 mg/ elbasvir 50 mg, Zepatier® - Chronic Hepatitis c, Liver Transplant Infection | Phase 4 | Terminated | Taichung Veterans General Hospital | 14 | 2019-02-14 | 2021-03-16 |
| Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication Elbasvir / Grazoprevir Oral Tablet [Zepatier], Cardiac MRI - Cardiovascular Diseases, Hepatitis C | Phase 4 | Completed | University of Maryland, Baltimore | 87 | 2018-11-18 | 2023-05-22 |
| Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in G1b Treatment-Naïve, HCV-Infected Patients Elbasvir 50 MG / Grazoprevir 100 MG Oral Tablet [Zepatier] - Chronic HCV Hepatitis | Phase 3 | Completed | Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo | 75 | 2018-09-19 | 2023-02-22 |
| Preemptive Zepatier Treatment in Donor HCV Positive to Recipient HCV Negative Cardiac Transplant Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin - Cardiac Transplant Disorder, Hepatitis C | Phase 4 | Withdrawn | Raymond T. Chung, MD | 2018-08-01 | 2018-12-20 | |
| Eight Weeks of Elbasvir/Grazoprevir in the Treatment of HCV Genotype 4 Elbasvir, Grazoprevir 50-100Mg Oral Tablet - Hepatitis C, Chronic | Phase 3 | Completed | King Fahad Medical City | 30 | 2018-07-01 | 2020-11-20 |
| Hepatitis C (HCV) Cure and Kidney Health Elbasvir / Grazoprevir Oral Tablet [Zepatier] - Hepatitis C | Unknown | San Francisco Veterans Affairs Medical Center | 50 | 2018-03-27 | 2018-04-18 | |
| Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079) EBR/GZR FDC Tablet, Placebo, Grazoprevir Oral Granules - HCV Infection | Phase 2 | Completed | Merck Sharp & Dohme LLC | 57 | 2018-01-25 | 2023-05-31 |
| A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment - ADVANCE HCV Study Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet, Psychological intervention, Sofosbuvir 400 MG - Hepatitis C | Phase 2 | Completed | University of Dundee | 129 | 2018-01-19 | 2021-11-18 |
| Efficacy and Tolerability of Grazoprevir and Elbasvir in Patients With Chronic Genotype 1 HCV and HIV Co-infection grazoprevir and elbasvir - Chronic Hepatitis C | Phase 4 | Completed | Taoyuan General Hospital | 40 | 2017-10-20 | 2018-12-20 |
| Open-Label Efficacy and Safety Study of the Elbasvir/ Grazoprevir Fixed Dose Combination Patients With Chronic HCV GT1b Elbasvir/ Grazoprevir 50/100 mg fixed dose combination - Chronic Hepatitis C Genotype 1B, Metabolic Syndrome | Phase 3 | Unknown | Institute Of Cardiology & Internal Diseases, Kazakhstan | 60 | 2017-10-01 | 2017-08-07 |
| HCV Treatment Immune Response With Grazoprevir/Elbasvir Before or After Renal Transplant Post-transplant Grazoprevir and Elbasvir - Hepatitis C, Renal Insufficiency, Chronic | Phase 4 | Completed | University of Maryland, Baltimore | 21 | 2017-05-01 | 2024-04-22 |
| Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV Co-infected Patients Grazoprevir 100 mg/d 8 weeks, Elbasvir 50 mg/d 8 weeks, Grazoprevir 100 mg/d 12 weeks - Hepatitis C, HIV | Phase 3 | Unknown | Fundacion Clinic per a la Recerca Biomédica | 62 | 2017-04-28 | 2019-02-15 |
| A Study for G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir Grazoprevir plus Elbasvir - Hepatitis C Viral, Chronic Kidney Disease stage3 | Phase 4 | Completed | Kyushu University | 80 | 2017-04-01 | 2019-06-03 |
| Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir - Hepatitis C | Completed | Hepa C | 130 | 2017-03-31 | 2019-02-11 | |
| Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) - Renal Failure | Phase 4 | Completed | Massachusetts General Hospital | 8 | 2017-02-01 | 2020-06-09 |
| Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, With Non-severe Fibrosis Elbasvir/Grazoprevir Fixed Dose Combination - Chronic HCV Infection | Phase 3 | Completed | University Hospital, Clermont-Ferrand | 117 | 2017-01-11 | 2026-08-24 |
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Hepatitis C (32) · Hepatitis C, Chronic (11) · Acquired Immunodeficiency Syndrome (4) · Kidney Failure, Chronic (2) · Renal Insufficiency (2) · Substance-Related Disorders (2) · Carcinoma, Hepatocellular (1) · Cardiovascular Diseases (1) · Cross Infection (1) · HIV Infections (1) · Hepatic Insufficiency (1) · Hepatitis, Viral, Human (1) · Homosexuality (1) · Liver Cirrhosis (1) · Metabolic Syndrome (1)
Merck Sharp & Dohme LLC (17) · University of Maryland, Baltimore (3) · Fundacion Clinic per a la Recerca Biomédica (2) · Valme University Hospital (2) · Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo (1) · Erasmus Medical Center (1) · Hepa C (1) · Institute Of Cardiology & Internal Diseases, Kazakhstan (1) · Istituto Clinico Humanitas (1) · Johns Hopkins University (1) · King Fahad Medical City (1) · Kyushu University (1) · M.D. Anderson Cancer Center (1) · Massachusetts General Hospital (1) · Qing XIe (1)
United States (12) · Spain (4) · Taiwan (2) · Belgium (1) · China (1) · Egypt (1) · France (1) · Germany (1) · Italy (1) · Japan (1) · Kazakhstan (1) · Netherlands (1) · Poland (1) · Saudi Arabia (1) · Sweden (1)
Ahmed O Kaseb, MD (1) · B Rijnders, PhD (1) · Chien-Yu Cheng (1) · David R Nelson, MD (1) · Dominique L Braun, MD (1) · Jennifer S Husson, MD (1) · John Dillon, MD (1)
PMID 28193518, PMID 29404492, PMID 29461687, PMID 28802814, PMID 28802816, PMID 30680407, PMID 30853642, PMID 37671831, PMID 24073301, PMID 25909356, PMID 26371152, PMID 26456905, PMID 27415157, PMID 27537841, PMID 27542322, PMID 27720838, PMID 27770561, PMID 27873094, PMID 27882706, PMID 28004322, PMID 28137633, PMID 28470815, PMID 28576451, PMID 28599618, PMID 29152828, PMID 29247332, PMID 29344726, PMID 29377515, PMID 29473975, PMID 29507971, PMID 29703432, PMID 30107485, PMID 30107494, PMID 30265418, PMID 30587935, PMID 30660617, PMID 30939489, PMID 31114268, PMID 31399460, PMID 31533734, PMID 32383275, PMID 32761122, PMID 33823783, PMID 34255381, PMID 34902265, PMID 35142658, PMID 35182741, PMID 35404384, PMID 35582875, PMID 35657133
2014 (7), 2015 (4), 2017 (2), 2016 (1)