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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR GLECAPREVIR; PIBRENTASVIR

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Clinical Trials for Glecaprevir; Pibrentasvir

Trial ID Title Status Sponsor Phase Summary
NCT02966795 A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection Not yet recruiting AbbVie Phase 3 A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir (ABT-493)/pibrentasvir (ABT-530) for an 8- or 12-week treatment duration in participants with chronic Hepatitis C Virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis, who are either HCV treatment-naïve or treatment experienced with interferon (IFN) or pegylated interferon (pegIFN) with or without ribavirin (RBV) (defined as P/R treatment-experienced) or sofosbuvir (SOF) plus RBV with or without pegIFN (defined as SOF plus RBV treatment-experienced).
NCT03067129 A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection Recruiting AbbVie Phase 3 An open-label study to assess the pharmacokinetics (PK), safety, and efficacy of glecaprevir (GLE)/pibrentasvir (PIB) in pediatric participants divided into 4 age groups: 3 to < 6, 6 to < 9, 9 to < 12, and 12 to < 18 years of age. Within each age group, some participants will be enrolled for intensive pharmacokinetics (IPK) to characterize the PK of a particular age group and the remainder of participants will be enrolled for the evaluation of safety and efficacy of each age group. Intensive PK sampling is designed to allow for dose adjustment, based on available PK and clinical data to achieve therapeutic exposures that have been safe and efficacious in adults. Part 1 of the study will enroll participants into Cohort 1; Cohort 1 will include participants who are in 12 to < 18 years of age who can swallow the adult formulation of GLE/PIB. Part 2 of the study will enroll participants in the remaining age groups into Cohorts 2, 3, and 4; participants in these cohorts will receive the pediatric formulation of GLE/PIB. All participants will receive GLE/PIB for 8, 12, or 16 weeks depending on their hepatitis C virus (HCV) genotype, cirrhosis, and prior treatment experience status.
NCT03069365 A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection and Renal Impairment Recruiting AbbVie Phase 3 This Phase 3b, open-label, non-randomized study will evaluate the efficacy and safety of Glecaprevir/Pibrentasvir (GLE/PIB) for 8, 12, or 16 weeks in in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection with or without compensated liver cirrhosis and with chronic renal impairment in both HCV treatment-naïve and prior treatment-experienced participants.
NCT03089944 A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis Recruiting AbbVie Phase 3 A Phase 3b, single arm, open-label, multicenter study to evaluate the safety and to demonstrate the non-inferiority of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with the glecaprevir (GLE)/pibrentasvir (PIB) combination regimen to the historical SVR12 rate of 12 weeks of treatment with the GLE/PIB in treatment-naïve adults with chronic HCV GT 1, 2, 4, 5, or 6 infection and compensated cirrhosis.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Glecaprevir; Pibrentasvir

Condition Name

Condition Name for Glecaprevir; Pibrentasvir
Intervention Trials
Hepatitis C Virus (HCV) 4
Hepatitis C 3
Hepatitis C, Chronic 1
HCV 1
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Condition MeSH

Condition MeSH for Glecaprevir; Pibrentasvir
Intervention Trials
Hepatitis C 10
Hepatitis 10
Hepatitis A 8
Hepatitis C, Chronic 7
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Clinical Trial Locations for Glecaprevir; Pibrentasvir

Trials by Country

Trials by Country for Glecaprevir; Pibrentasvir
Location Trials
United States 32
Puerto Rico 4
Canada 3
Australia 3
Italy 2
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Trials by US State

Trials by US State for Glecaprevir; Pibrentasvir
Location Trials
California 4
Florida 4
Maryland 3
New York 3
Texas 2
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Clinical Trial Progress for Glecaprevir; Pibrentasvir

Clinical Trial Phase

Clinical Trial Phase for Glecaprevir; Pibrentasvir
Clinical Trial Phase Trials
Phase 4 1
Phase 3 8
Early Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Glecaprevir; Pibrentasvir
Clinical Trial Phase Trials
Recruiting 7
Not yet recruiting 3
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Clinical Trial Sponsors for Glecaprevir; Pibrentasvir

Sponsor Name

Sponsor Name for Glecaprevir; Pibrentasvir
Sponsor Trials
AbbVie 7
University of Maryland 1
Johns Hopkins University 1
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Sponsor Type

Sponsor Type for Glecaprevir; Pibrentasvir
Sponsor Trials
Industry 7
Other 5
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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Cerilliant
Colorcon
Boehringer Ingelheim
Covington
Johnson and Johnson
UBS
Chubb
Mallinckrodt

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