12 completed, 3 unknown, 1 withdrawn. 16 Phase 3, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 16 | Completed 12, Unknown 3, Withdrawn 1 |
| Phase 2 | 3 | Completed 3 |
Follow grazoprevir: new trials by email Literature Review of grazoprevir trials Research Report on grazoprevir
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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Pilot Study Evaluate Efficacy of Grazoprevir + Elbasvir for 12 or 16 Weeks in Liver Transplant Recipients. Grazoprevir 100 mg/day, Elbasvir 50 mg/d, Elbasvir 50 mg/day - Liver Transplantation, Hepatitis C | Phase 3 | Withdrawn | Fundacion Clinic per a la Recerca Biomédica | 2016-08-03 | 2025-06-22 | |
| Swiss HCVree Trial grazoprevir/elbasvir, ribavirin, Behavioural Intervention - Hepatitis C, HIV | Phase 3 | Completed | University of Zurich | 150 | 2016-06-01 | 2018-08-31 |
| Study to Investigate Tolerability and Efficacy of MK5172 / MK8742 Without Ribavirin for 12 Weeks in Patients With Chronic HCV G1b Infection With Compensated Cirrhosis MK5172 /MK8742 - Hepatitis C, Compensated Cirrhosis | Phase 3 | Unknown | Istituto Clinico Humanitas | 120 | 2016-05-01 | 2016-04-08 |
| Dutch Acute HCV in HIV Study (DAHHS-2): Grazoprevir/Elbasvir for Acute HCV Grazoprevir/Elbasvir 100mg/50mg - Acute Hepatitis C, Human Immunodeficiency Virus | Phase 3 | Completed | Erasmus Medical Center | 80 | 2016-02-01 | 2019-07-08 |
| Efficacy and Safety of Combination Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Sofosbuvir + Pegylated Interferon + Ribavirin in Hepatitis C Virus Genotype 1, 4 or 6 Infection (MK-5172-077) Sofosbuvir, PegIntron, Ribavirin - Hepatitis C | Phase 3 | Completed | Merck Sharp & Dohme LLC | 257 | 2015-02-27 | 2018-10-03 |
| An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus (HCV) Genotype (GT)1, 4, or 6 Infection in Treatment-Naïve Participants Who Are on Opiate Substitution Therapy (MK-5172-062) Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet (MK-5172A), Placebo to Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet - Chronic Hepatitis C | Phase 3 | Completed | Merck Sharp & Dohme LLC | 301 | 2014-09-02 | 2019-12-05 |
| Study of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Japanese Participants With Chronic Hepatitis C (MK-5172-058) Grazoprevir, Elbasvir, Placebo to Grazoprevir - Hepatitis C | Phase 2 / Phase 3 | Completed | Merck Sharp & Dohme LLC | 399 | 2014-08-01 | 2018-09-24 |
| 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) Grazoprevir 100mg / Elbasvir 50 mg FDC, Placebo to Grazoprevir / Elbasvir 50 mg FDC - Chronic Hepatitis C Virus | Phase 3 | Completed | Merck Sharp & Dohme LLC | 421 | 2014-06-05 | 2018-10-02 |
| 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) Grazoprevir 100 mg/Elbasvir 50 mg fixed-dose combination tablets - Chronic Hepatitis C | Phase 3 | Completed | Merck Sharp & Dohme LLC | 218 | 2014-06-03 | 2021-02-05 |
| Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Chronic Hepatitis C Participants With Child-Pugh (CP)-B Hepatic Insufficiency (MK-5172-059) Grazoprevir, Elbasvir, MK-5172A - Chronic Hepatitis C | Phase 2 / Phase 3 | Completed | Merck Sharp & Dohme LLC | 40 | 2014-05-09 | 2019-06-26 |
| Safety and Efficacy of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Participants With Chronic Hepatitis C and Chronic Kidney Disease (MK-5172-052) Grazoprevir, Elbasvir, Placebo to Grazoprevir - Hepatitis C Virus | Phase 2 / Phase 3 | Completed | Merck Sharp & Dohme LLC | 237 | 2014-03-17 | 2018-09-24 |
Hepatitis C (11) · Hepatitis C, Chronic (5) · Acquired Immunodeficiency Syndrome (1) · Homosexuality (1) · Liver Cirrhosis (1) · Metabolic Syndrome (1)
Merck Sharp & Dohme LLC (7) · Fundacion Clinic per a la Recerca Biomédica (2) · Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo (1) · Erasmus Medical Center (1) · Institute Of Cardiology & Internal Diseases, Kazakhstan (1) · Istituto Clinico Humanitas (1) · King Fahad Medical City (1) · University Hospital, Clermont-Ferrand (1) · University of Zurich (1)
Belgium (1) · France (1) · Italy (1) · Kazakhstan (1) · Netherlands (1) · Saudi Arabia (1) · Spain (1) · Switzerland (1)
B Rijnders, PhD (1) · Dominique L Braun, MD (1)
PMID 29404492, PMID 28193518, PMID 29461687, PMID 26456905, PMID 27537841, PMID 27542322, PMID 27770561, PMID 27873094, PMID 28576451, PMID 29344726, PMID 30107485, PMID 30107494, PMID 30587935, PMID 30660617, PMID 30680407, PMID 30939489, PMID 31533734, PMID 32383275, PMID 32761122, PMID 33823783, PMID 35142658, PMID 35404384, PMID 35939812, PMID 36146760, PMID 37096802
2014 (5), 2015 (2), 2016 (1), 2017 (1)