Numerous clinical trials ranging from Early Phase 1 through Phase 4 evaluate glecaprevir for chronic hepatitis C virus (HCV) infection across multiple genotypes, including special populations with renal impairment, hepatic impairment, end-stage renal disease, and pregnancy complications. Sponsored by pharmaceutical developers such as AbbVie alongside academic medical centers including Washington University School of Medicine, Johns Hopkins University, and Massachusetts General Hospital, these studies comprise both completed trials supporting marketing approvals and active recruitment assessing real-world outcomes and optimized treatment delivery.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT03855917 | RECRUITING | Hepatitis C |
Kirby Institute |
2020-02-11 | PHASE4 |
| NCT07040319 | RECRUITING | Hepatitis C |
National Institute of Allergy and Infectious Diseases (NIAID) |
2026-06-25 | PHASE1; PHASE2 |
| NCT05637879 | RECRUITING | PTSD |
White River Junction Veterans Affairs Medical Center |
2023-12-18 | PHASE2; PHASE3 |
| NCT04508907 | ACTIVE_NOT_RECRUITING | Hepatitis C; Kidney Transplant; Complications; Heart Transplant Infection |
Mayo Clinic |
2020-09-10 | PHASE4 |
| NCT03981211 | TERMINATED | Hepatitis C; Liver Inflammation; Liver Cirrhoses |
Kirby Institute |
2021-02-12 | |
| NCT05582681 | TERMINATED | Hepatitis C |
Weill Medical College of Cornell University |
2022-11-11 | PHASE4 |
| NCT04903626 | COMPLETED | Hepatitis C Virus (HCV) |
AbbVie |
2021-08-24 | PHASE3 |
| NCT05446857 | COMPLETED | PTSD |
White River Junction Veterans Affairs Medical Center |
2023-04-01 | PHASE2; PHASE3 |
| NCT04575896 | COMPLETED | End Stage Renal Disease; Hepatitis C |
Johns Hopkins University |
2020-11-20 | PHASE4 |
| NCT04515797 | TERMINATED | Kidney Failure; Hepatitis C; Kidney Disease, Chronic |
Massachusetts General Hospital |
2021-05-01 | PHASE4 |
| NCT04042740 | COMPLETED | Hepatitis C Infection; HIV Infection |
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
2019-11-20 | PHASE2 |
| NCT04682509 | COMPLETED | ESRD |
NYU Langone Health |
2022-03-20 | EARLY_PHASE1 |
| NCT04596475 | COMPLETED | Hepatitis C; Hepatitis C Virus Infection, Response to Therapy of |
University of California, San Diego |
2021-05-28 | PHASE1; PHASE2 |
| NCT04235049 | WITHDRAWN | HCV Infection |
University of Maryland, Baltimore |
2021-10-01 | PHASE4 |
| NCT03492112 | COMPLETED | Hepatitis C |
Kirby Institute |
2019-09-10 | |
| NCT04614142 | WITHDRAWN | End Stage Renal Disease; Chronic Hepatitis c |
Massachusetts General Hospital |
2020-11-13 | PHASE4 |
| NCT02939989 | COMPLETED | Hepatitis C Virus Infection |
AbbVie |
2016-11-21 | PHASE3 |
| NCT02634008 | COMPLETED | Hepatitis C, Acute |
Kirby Institute |
2016-06 | PHASE3 |
| NCT03801707 | COMPLETED | Kidney Transplant; Hepatitis C; HCV |
Ohio State University |
2019-03-22 | PHASE2; PHASE3 |
| NCT03623568 | WITHDRAWN | Kidney Failure; Kidney Diseases; Hepatitis C |
Raymond T. Chung, MD |
2019-02-15 | PHASE4 |
| NCT04017338 | UNKNOWN | Lung Transplant Infection; Heart Transplant Infection; Kidney Transplant Infection; Kidney Pancreas Infection; Hepatitis C |
Jordan Feld |
2018-08-06 | PHASE3 |
| NCT04577482 | Completed | Hepatitis C Virus (HCV) |
AbbVie |
2020-10-07 | -- |
| NCT03067129 | COMPLETED | Hepatitis C Virus (HCV) |
AbbVie |
2017-03-20 | PHASE2; PHASE3 |
| NCT03781726 | COMPLETED | Renal Failure Chronic; Hepatitis C |
Raymond Chung |
2019-04-10 | PHASE4 |
| NCT03627299 | COMPLETED | End Stage Renal Disease; Hepatitis C |
Johns Hopkins University |
2018-09-25 | PHASE4 |
| NCT03089944 | COMPLETED | Hepatitis C Virus (HCV) |
AbbVie |
2017-04-28 | PHASE3 |
| NCT03219216 | COMPLETED | Hepatitis C Virus (HCV) |
AbbVie |
2018-06-06 | PHASE3 |
| NCT03092375 | COMPLETED | Hepatitis C; HCV |
University of Florida |
2017-04-20 | PHASE3 |
| NCT03117569 | COMPLETED | Hepatitis C, Chronic |
Kirby Institute |
2017-08-21 | PHASE3 |
| NCT03235349 | COMPLETED | Hepatitis C Virus (HCV) |
AbbVie |
2017-09-29 | PHASE3 |
| NCT03222583 | COMPLETED | Hepatitis C Virus (HCV) |
AbbVie |
2017-10-04 | PHASE3 |
| NCT03364725 | UNKNOWN | Hepatitis C; Addict Heroin |
Id Care |
2018-01-15 | PHASE4 |
| NCT03212521 | COMPLETED | Hepatitis C Virus (HCV) |
AbbVie |
2017-08-07 | PHASE3 |
| NCT02966795 | COMPLETED | Hepatitis C Virus (HCV) |
AbbVie |
2017-01-25 | PHASE3 |
| NCT03069365 | COMPLETED | Hepatitis C Virus (HCV) |
AbbVie |
2017-03-28 | PHASE3 |
| NCT03303599 | Completed | Hepatitis C |
AbbVie |
2017-11-13 | -- |
| NCT02692703 | COMPLETED | Chronic Hepatitis C; HCV; Hepatitis C Virus |
AbbVie |
2016-04-22 | PHASE3 |
| NCT02441283 | Completed | Hepatitis C |
AbbVie |
2015-06-22 | Phase 2|Phase 3 |
| NCT02442258 | Completed | Renal Impairment |
AbbVie |
2015-03 | Phase 1 |
| NCT02296905 | Completed | Hepatic Impairment |
AbbVie |
2014-10 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2026-07-29)
Check the
Glecaprevir
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
Note: Technical data last updated: Sep 1, 2026.