Clinical Trials

Numerous clinical trials evaluate Paritaprevir for chronic hepatitis C virus infection across various genotypes, including genotype 1, as well as in populations with hepatitis B coinfection or renal disease. Spanning Phase 1 pharmacokinetic evaluations to Phase 4 studies of direct-acting antiviral combination regimens, these trials are sponsored by pharmaceutical developers like AbbVie alongside academic medical centers such as Assiut University and National Taiwan University Hospital. While the majority of these studies are completed, others have been terminated, withdrawn, or remain under an unknown status.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02460133 UNKNOWN
Hepatitis C Virus
Nova Scotia Health Authority
 2015-07-10 PHASE4
NCT02219490 COMPLETED
Chronic Hepatitis C Virus (HCV) Infection Genotype 1
AbbVie
 2014-10-30 PHASE3
NCT02167945 COMPLETED
Chronic Hepatitis C Virus (HCV) Infection Genotype 1
AbbVie
 2014-06-12 PHASE3
NCT02555943 COMPLETED
Chronic Hepatitis C Infection; HBV Coinfection; Hepatitis B Reactivation
Humanity and Health Research Centre
 2015-02 PHASE2; PHASE3
NCT02634008 COMPLETED
Hepatitis C, Acute
Kirby Institute
 2016-06 PHASE3
NCT02486406 COMPLETED
Chronic Hepatitis C Infection
AbbVie
 2015-10-28 PHASE2; PHASE3
NCT02786537 COMPLETED
Chronic Hepatitis C
University of Florida
 2016-06 PHASE4
NCT03549832 COMPLETED
HCV Coinfection
Assiut University
 2018-01-01
NCT02992457 COMPLETED
Hepatitis C
Tanta University
 2015-01 PHASE4
NCT02874066 COMPLETED
Hepatitis Viruses
National Taiwan University Hospital
 2017-03-13 PHASE4
NCT03003338 TERMINATED
Hepatitis C, Chronic
Hannover Medical School
 2017-10-24 PHASE4
NCT03296930 UNKNOWN
Antiviral Drug Adverse Reaction
Assiut University
 2017-10-01 PHASE4
NCT03499639 COMPLETED
End-stage Renal Disease; HCV Coinfection
Assiut University
 2018-05-01 PHASE4
NCT02806362 WITHDRAWN
Chronic Hepatitis C Virus
AbbVie
 2016-09 PHASE3
NCT02194998 TERMINATED
HIV Infections; Hepatitis C
National Institute of Allergy and Infectious Diseases (NIAID)
 2015-09-16 PHASE2
NCT03341988 COMPLETED
Hepatitis C
Assiut University
 2017-11-22 PHASE1
NCT02646111 UNKNOWN
Hepatitis C
Tel-Aviv Sourasky Medical Center
 2016-01 PHASE3
NCT03067883 UNKNOWN
Chronic Hepatitis c
Ain Shams University
 2016-11-09 PHASE2
NCT02950870 UNKNOWN
Chronic Hepatitis, C Virus
University of Modena and Reggio Emilia
 2016-12 PHASE4
NCT04391985 COMPLETED
Chronic Hepatitis C Virus Infection
Beni-Suef University
 2017-03-01 PHASE1; PHASE2
NCT04378608 COMPLETED
Hepatitis C Virus Infection
Beni-Suef University
 2017-01-05 PHASE1; PHASE2
NCT03710252 COMPLETED
Chronic Hepatitis C
American Research Corporation
 2016-03 PHASE4
NCT02498015 COMPLETED
Hepatitis C, Chronic
Kirby Institute
 2016-08 PHASE4
NCT02292719 COMPLETED
Chronic Hepatitis C Virus Infection
AbbVie
 2014-12-19 PHASE2
NCT01609933 COMPLETED
Chronic Hepatitis C
AbbVie (prior sponsor, Abbott)
 2012-12-18 PHASE2
NCT02461745 COMPLETED
Hepatitis C, Chronic
Kaiser Permanente
 2015-06 PHASE4
NCT02734173 COMPLETED
Hepatitis C
Ottawa Hospital Research Institute
 2015-07 PHASE4
NCT02207088 COMPLETED
Chronic Hepatitis C; Hepatitis C Virus; Compensated Cirrhosis; Severe Renal Impairment; End-stage Renal Disease
AbbVie
 2014-09-23 PHASE3
NCT02487199 COMPLETED
Hepatitis C Virus (HCV)
AbbVie
 2015-09-30 PHASE3
NCT01782495 COMPLETED
Chronic Hepatitis C Infection
AbbVie
 2013-02-25 PHASE2
NCT02356562 COMPLETED
Chronic Hepatitis C Infection
AbbVie
 2015-02-03 PHASE2
NCT02609659 COMPLETED
Hepatitis C Virus (HCV)
AbbVie
 2015-10-28 PHASE3
NCT02517515 COMPLETED
Hepatitis C Virus (HCV)
AbbVie
 2015-07 PHASE3
NCT01773070 COMPLETED
Hepatitis C
AbbVie (prior sponsor, Abbott)
 2013-06 PHASE3
NCT02517528 COMPLETED
Chronic Hepatitis C Virus (HCV)
AbbVie
 2015-07-20 PHASE3
NCT02504099 TERMINATED
Chronic Hepatitis C Infection
AbbVie
 2015-07 PHASE3
NCT02582632 COMPLETED
Hepatitis C Infection; Hepatitis C Virus
AbbVie
 2015-11-24 PHASE3
NCT02442284 COMPLETED
Chronic Hepatitis C; Cirrhosis; Hepatitis C Virus
AbbVie
 2015-05-13 PHASE3
NCT02247401 COMPLETED
HCV; Hepatitis C Infection; Genotype 4
AbbVie
 2014-11-04 PHASE3
NCT02476617 COMPLETED
Chronic Hepatitis C; Hepatitis C (HCV); Hepatitis C Genotype 1a
AbbVie
 2015-06 PHASE3
NCT02265237 COMPLETED
Hepatitis C Virus
AbbVie
 2014-10-28 PHASE3
NCT01939197 COMPLETED
Hepatitis C Virus Infection; Human Immunodeficiency Virus Infection; Chronic Hepatitis C; Compensated Cirrhosis and Non-cirrhotics
AbbVie
 2013-08-30 PHASE2; PHASE3
NCT02442271 COMPLETED
Chronic Hepatitis C Infection
AbbVie
 2015-04-27 PHASE3
NCT02219477 COMPLETED
Chronic Hepatitis C; Decompensated Cirrhosis; Hepatitis C Virus
AbbVie
 2014-11-24 PHASE3
NCT02493855 COMPLETED
Chronic Hepatitis C; Hepatitis C (HCV); Hepatitis C Genotype 1a
AbbVie
 2015-06 PHASE2
NCT02581020 Completed
Hepatitis C Virus
AbbVie
 2016-01-14 --
NCT02216422 COMPLETED
Chronic Hepatitis C Virus (HCV) Infection
AbbVie
 2014-09 PHASE3
NCT02399345 COMPLETED
Chronic Hepatitis C Virus (HCV Infection Genotype 1)
AbbVie
 2015-03 PHASE3
NCT02534870 COMPLETED
Healthy Volunteer
AbbVie
 2015-09 PHASE1
NCT02534870 Completed
Healthy Volunteer
AbbVie
 2015-09 Phase 1
NCT02734173 Completed
Hepatitis C
Ottawa Hospital Research Institute|AbbVie
 2015-07 Phase 4
NCT02219503 COMPLETED
Chronic Hepatitis C Infection; Compensated Cirrhosis
AbbVie
 2014-09 PHASE3
NCT01995071 COMPLETED
Chronic Hepatitis C; Hepatitis C Virus; Compensated Cirrhosis
AbbVie
 2013-11 PHASE2
NCT02023112 COMPLETED
Hepatitis C Virus
AbbVie
 2014-01 PHASE3
NCT02068222 COMPLETED
Chronic Hepatitis C; Hepatitis C Virus
AbbVie
 2014-04 PHASE2
NCT01854697 COMPLETED
Chronic Hepatitis C Infection
AbbVie
 2013-03 PHASE3
NCT01854528 COMPLETED
Chronic Hepatitis C Infection
AbbVie
 2013-06 PHASE3
NCT02023099 COMPLETED
Chronic Hepatitis C Infection
AbbVie
 2013-12 PHASE3
NCT01685203 COMPLETED
Hepatitis C, Chronic
AbbVie (prior sponsor, Abbott)
 2012-08 PHASE2
NCT01672983 COMPLETED
Chronic Hepatitis C Infection
AbbVie (prior sponsor, Abbott)
 2012-07 PHASE2
NCT02052362 COMPLETED
Absolute Bioavailability
AbbVie
 2014-01 PHASE1
NCT01704755 COMPLETED
Chronic Hepatitis C Infection; Compensated Cirrhosis
AbbVie (prior sponsor, Abbott)
 2012-10 PHASE3
NCT01674725 COMPLETED
Chronic Hepatitis C Infection
AbbVie (prior sponsor, Abbott)
 2012-08 PHASE3
NCT01833533 COMPLETED
Chronic Hepatitis C Infection
AbbVie
 2013-03 PHASE3
NCT01911845 COMPLETED
Chronic Hepatitis C Infection; Chronic Hepatitis C
AbbVie
 2013-04 PHASE2
NCT01767116 COMPLETED
Chronic Hepatitis C Infection
AbbVie (prior sponsor, Abbott)
 2012-12 PHASE3
NCT01715415 COMPLETED
Chronic Hepatitis C Infection
AbbVie (prior sponsor, Abbott)
 2012-11 PHASE3
NCT01716585 COMPLETED
Chronic Hepatitis C Infection
AbbVie (prior sponsor, Abbott)
 2012-11 PHASE3
NCT01458535 COMPLETED
Hepatitis C Virus
AbbVie (prior sponsor, Abbott)
 2011-09 PHASE2
NCT01911845 Completed
Chronic Hepatitis C Infection|Chronic Hepatitis C
AbbVie
 2013-04 Phase 2
NCT01464827 COMPLETED
Chronic Hepatitis C; Hepatitis C (HCV); Hepatitis C Genotype 1
AbbVie (prior sponsor, Abbott)
 2011-10 PHASE2
NCT01563536 COMPLETED
Chronic Hepatitis C Infection
AbbVie (prior sponsor, Abbott)
 2012-02 PHASE2
NCT01306617 COMPLETED
Chronic Hepatitis C Infection; Hepatitis C; Hepatitis C Virus
AbbVie (prior sponsor, Abbott)
 2011-02 PHASE2
NCT01074008 COMPLETED
Hepatitis C; HCV; Chronic Hepatitis C Infection; Hepatitis C Genotype 1
AbbVie (prior sponsor, Abbott)
 2010-03 PHASE2
NCT01221298 COMPLETED
Hepatitis C; HCV; Chronic Hepatitis C Infection; Hepatitis C Genotype 1
AbbVie (prior sponsor, Abbott)
 2010-10 PHASE2
NCT01091649 COMPLETED
Healthy
Abbott
 2010-02 PHASE1
NCT00931281 COMPLETED
HCV Infection
Abbott
 2009-06 PHASE1
NCT00850044 COMPLETED
HCV Infection
AbbVie
 2009-02 PHASE1
NCT00909311 COMPLETED
HCV Infection
Abbott
 2009-05 PHASE1

(data from https://clinicaltrials.gov, updated on 2024-08-23)

Check the Paritaprevir (ABT-450) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Paritaprevir functions as a potent inhibitor of the hepatitis C virus nonstructural protein 3/4A (NS3/4A) protease, directly binding to the catalytic site to block the proteolytic cleavage of the precursor viral polyprotein into essential functional units. By disrupting the assembly of the viral replication complex, it halts viral polyprotein processing and viral maturation within host hepatocytes, ultimately facilitating rapid viral clearance in patients suffering from chronic hepatitis C 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>).

Jump to

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