Clinical Trials

Grazoprevir has been evaluated in numerous Phase 1 through Phase 4 clinical trials to assess its safety and efficacy as monotherapy or combination therapy for chronic hepatitis C virus (HCV) infection. These studies encompass diverse patient populations, ranging from uncomplicated HCV cases to complex conditions involving chronic kidney disease, HIV co-infection, compensated cirrhosis, and hepatocellular carcinoma. Reaching completed, terminated, or withdrawn statuses, these trials have been sponsored by pharmaceutical entities like Merck Sharp & Dohme LLC alongside institutional partners such as University Hospital Toulouse and the HIV Netherlands Australia Thailand Research Collaboration.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02940496 COMPLETED
BCLC Stage B Hepatocellular Carcinoma; BCLC Stage C Hepatocellular Carcinoma; Hepatitis C Infection; Refractory Liver Carcinoma; Stage III Hepatocellular Carcinoma AJCC v7; Stage IIIA Hepatocellular Carcinoma AJCC v7; Stage IIIB Hepatocellular Carcinoma AJCC v7; Stage IIIC Hepatocellular Carcinoma AJCC v7; Stage IV Hepatocellular Carcinoma AJCC v7; Stage IVA Hepatocellular Carcinoma AJCC v7; Stage IVB Hepatocellular Carcinoma AJCC v7
M.D. Anderson Cancer Center
 2016-12-09 PHASE2
NCT03823911 COMPLETED
Cardiovascular Diseases; Hepatitis C; Hiv
University of Maryland, Baltimore
 2018-11-18 PHASE4
NCT02902120 COMPLETED
Hepatitis C; Renal Insufficiency, Chronic; Disorder of Transplanted Kidney
University of Maryland, Baltimore
 2017-05-01 PHASE4
NCT04546802 WITHDRAWN
Hepatocellular Carcinoma; Hepatoma; Liver Cell Carcinoma; Hepatitis C
Bayside Health
 2019-09 PHASE3
NCT03037151 UNKNOWN
Compensated Cirrhosis
The HIV Netherlands Australia Thailand Research Collaboration
 2018-08-01 PHASE4
NCT03026023 WITHDRAWN
Cardiac Transplant Disorder; Hepatitis C
Raymond T. Chung, MD
 2018-08-01 PHASE4
NCT03723824 TERMINATED
Chronic Hepatitis c; Liver Transplant Infection; Kidney Transplant Infection
Taichung Veterans General Hospital
 2019-02-14 PHASE4
NCT03236506 COMPLETED
Hepatitis C
University of Dundee
 2018-01-19 PHASE2
NCT03797066 TERMINATED
Hepatitis C, Chronic
King's College Hospital NHS Trust
 2019-03-23 PHASE4
NCT03578640 COMPLETED
Hepatitis C, Chronic
King Fahad Medical City
 2018-07-01 PHASE3
NCT03381859 WITHDRAWN
Hepatitis C Virus Infection, Response to Therapy of
University of Maryland, Baltimore
 2019-12-01 PHASE4
NCT03496233 COMPLETED
Chronic HCV Hepatitis
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
 2018-09-19 PHASE3
NCT03365635 COMPLETED
Hepatitis C; Hemodialysis; Nosocomial Infection
University of Pennsylvania
 2019-09-22 PHASE4
NCT03420300 COMPLETED
Hepatitis C
National Taiwan University Hospital
 2018-06-05 PHASE4
NCT03379506 COMPLETED
HCV Infection
Merck Sharp & Dohme LLC
 2018-01-25 PHASE2
NCT02945150 COMPLETED
Renal Failure
Massachusetts General Hospital
 2017-02-01 PHASE4
NCT03817619 COMPLETED
Hepatitis C; Deglutition Disorders
Radboud University Medical Center
 2019-03-28 PHASE1
NCT02786537 COMPLETED
Chronic Hepatitis C
University of Florida
 2016-06 PHASE4
NCT03093415 COMPLETED
Hepatitis C; Substance Use Disorders; Substance Abuse, Intravenous
Oregon Health and Science University
 2017-05-30 PHASE4
NCT03585101 WITHDRAWN
Hepatitis C
University of California, Los Angeles
 2018-08 PHASE4
NCT02895958 TERMINATED
Hepatitis C
Mater Misericordiae University Hospital
 2018-03-15 PHASE4
NCT02897596 UNKNOWN
Hepatitis C; HIV
Fundacion Clinic per a la Recerca Biomédica
 2017-04-28 PHASE3
NCT03222167 UNKNOWN
Chronic Hepatitis C Genotype 1B; Metabolic Syndrome; Fibrosis, Liver; Cirrhoses, Liver
Institute Of Cardiology & Internal Diseases, Kazakhstan
 2017-10 PHASE3
NCT03022006 UNKNOWN
Chronic Hepatitis C
Norte Study Group
 2017-01-15 PHASE4
NCT03127358 COMPLETED
Hepatitis C; Medication Adherence
Albert Einstein College of Medicine
 2017-11-14
NCT03143998 WITHDRAWN
Hepatitis C
Merck Sharp & Dohme LLC
 2018-02-12 PHASE4
NCT02886624 COMPLETED
Acute Hepatitis C; HIV
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
 2017-05-31 PHASE2
NCT03098121 COMPLETED
Chronic Hepatitis C
Taoyuan General Hospital
 2017-10-20 PHASE4
NCT02973503 COMPLETED
Chronic HCV Infection
University Hospital, Clermont-Ferrand
 2017-01-11 PHASE3
NCT02940691 TERMINATED
Hepatitis C
Kirby Institute
 2017-05-01 PHASE4
NCT03359746 UNKNOWN
Hepatitis C
King Faisal Specialist Hospital & Research Center
 2017-12-15 PHASE4
NCT03111108 COMPLETED
Hepatitis C Virus (HCV) Infection
Merck Sharp & Dohme LLC
 2017-06-20 PHASE4
NCT03186365 COMPLETED
Hepatitis C, Chronic
Kaohsiung Medical University Chung-Ho Memorial Hospital
 2017-06-12 PHASE3
NCT03110055 UNKNOWN
HCV, HCC
Tel-Aviv Sourasky Medical Center
 2017-05-01
NCT02600325 COMPLETED
Acute Hepatitis C; Human Immunodeficiency Virus; Hepatitis C
Erasmus Medical Center
 2016-02 PHASE3
NCT02785666 COMPLETED
Hepatitis C; HIV
University of Zurich
 2016-06 PHASE3
NCT03144635 COMPLETED
Hepatitis C Viral; Chronic Kidney Disease stage3
Kyushu University
 2017-04-01 PHASE4
NCT03105349 WITHDRAWN
HCV
Fundacion SEIMC-GESIDA
 2017-07-01 PHASE4
NCT03105349 Withdrawn
HCV
Fundacion SEIMC-GESIDA
 2017-07-01 Phase 4
NCT02890719 WITHDRAWN
Liver Transplantation; Hepatitis C
Fundacion Clinic per a la Recerca Biomédica
 2016-08-03 PHASE3
NCT03145623 Completed
Hepatitis C|Chronic Kidney Diseases
University Hospital Toulouse|MSD France
 2017-06-02 --
NCT02781649 COMPLETED
End-Stage Renal Disease; Hepatitis C
Johns Hopkins University
 2016-07-20 PHASE4
NCT02647632 COMPLETED
Hepatitis C
ANRS, Emerging Infectious Diseases
 2016-01 PHASE2
NCT02973503 Completed
Chronic HCV Infection
University Hospital Clermont-Ferrand|Merck Sharp & Dohme LLC
 2017-01-11 Phase 3
NCT02601573 COMPLETED
Hepatitis C
Merck Sharp & Dohme LLC
 2016-01-05 PHASE2
NCT02251990 COMPLETED
Hepatitis C
Merck Sharp & Dohme LLC
 2015-01-28 PHASE3
NCT02332720 COMPLETED
Hepatitis C
Merck Sharp & Dohme LLC
 2015-01-28 PHASE2
NCT02332707 COMPLETED
Hepatitis C
Merck Sharp & Dohme LLC
 2015-01-22 PHASE2
NCT02204475 WITHDRAWN
Hepatitis C
Merck Sharp & Dohme LLC
 2014-11 PHASE3
NCT02252016 COMPLETED
Hepatitis C
Merck Sharp & Dohme LLC
 2014-10-22 PHASE3
NCT02358044 COMPLETED
Hepatitis C
Merck Sharp & Dohme LLC
 2015-02-27 PHASE3
NCT02133131 COMPLETED
Hepatitis C
Merck Sharp & Dohme LLC
 2014-06-13 PHASE2
NCT02203149 COMPLETED
Hepatitis C
Merck Sharp & Dohme LLC
 2014-08-01 PHASE2; PHASE3
NCT02105688 COMPLETED
Chronic Hepatitis C
Merck Sharp & Dohme LLC
 2014-09-02 PHASE3
NCT02105454 COMPLETED
Hepatitis C Virus
Merck Sharp & Dohme LLC
 2014-05-23 PHASE2
NCT02105701 COMPLETED
Hepatitis C Infection
Merck Sharp & Dohme LLC
 2014-06-05 PHASE3
NCT02092350 COMPLETED
Hepatitis C Virus
Merck Sharp & Dohme LLC
 2014-03-17 PHASE2; PHASE3
NCT02115321 COMPLETED
Chronic Hepatitis C
Merck Sharp & Dohme LLC
 2014-05-09 PHASE2; PHASE3
NCT02105467 COMPLETED
Chronic Hepatitis C Virus
Merck Sharp & Dohme LLC
 2014-06-05 PHASE3
NCT01717326 COMPLETED
Hepatitis C
Merck Sharp & Dohme LLC
 2013-02-07 PHASE2
NCT02105662 COMPLETED
Chronic Hepatitis C
Merck Sharp & Dohme LLC
 2014-06-03 PHASE3
NCT01932762 COMPLETED
Hepatitis C
Merck Sharp & Dohme LLC
 2013-10-01 PHASE2
NCT01390428 COMPLETED
Hepatitis C
Merck Sharp & Dohme LLC
 2011-07-28 PHASE1
NCT01537900 COMPLETED
Hepatitis C
Merck Sharp & Dohme LLC
 2013-10-01 PHASE1
NCT01937975 COMPLETED
Chronic Hepatitis C; Renal Impairment
Merck Sharp & Dohme LLC
 2013-09-06 PHASE1
NCT01716156 COMPLETED
Hepatitis C
Merck Sharp & Dohme LLC
 2013-01-18 PHASE2
NCT01710501 COMPLETED
Chronic Hepatitis C (CHC)
Merck Sharp & Dohme LLC
 2012-12-07 PHASE2
NCT01353911 COMPLETED
Hepatitis C, Chronic
Merck Sharp & Dohme LLC
 2011-06-27 PHASE2
NCT00998985 COMPLETED
Hepatitis C
Merck Sharp & Dohme LLC
 2010-02-23 PHASE1
NCT01547312 WITHDRAWN
Chronic Hepatitis C
Merck Sharp & Dohme LLC
 2012-05 PHASE1
NCT01440595 TERMINATED
Hepatitis C, Chronic
Merck Sharp & Dohme LLC
 2011-11-28 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-07-15)

Check the Grazoprevir product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Grazoprevir is a potent inhibitor of the hepatitis C virus (HCV) NS3/4A protease complex that reversibly binds to the enzymatic active site, thereby blocking viral polyprotein cleavage necessary for replication. This inhibition halts viral RNA replication and assembly in host hepatocytes, leading to rapid viral clearance and clinical efficacy in patients with chronic HCV infection.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.