A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection
NCT02966795 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2021-07-30
Summary
A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir 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 respectively.
Conditions
- Hepatitis C Virus (HCV)
Interventions
- DRUG
-
Glecaprevir/Pibrentasvir
Fixed-dose combination tablets taken orally once a day.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
AbbVie Inc. · AbbVie
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-01-25
- Primary Completion
- 2018-06-06
- Completion
- 2018-08-29
- FDA Drug
- Yes
Countries
- United States
- Australia
- Belgium
- Canada
- France
- New Zealand
- Singapore
- South Africa
- Vietnam
Study Locations
More Related Trials
-
Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)
NCT04903626 ·Status: COMPLETED ·Phase: PHASE3
-
Trial of Simplified Treatment Monitoring for 8 Weeks Glecaprevir/Pibrentasvir in Chronic Hepatitis C Patients
NCT03117569 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With Compensated Cirrhosis and With or Without Human Immunodeficiency Virus Co-Infection
NCT03235349 ·Status: COMPLETED ·Phase: PHASE3
-
Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6
NCT03341871 ·Status: COMPLETED
-
Study of Oral Glecaprevir/Pibrentasvir Tablets in Participants Aged 12 Years or Older With Chronic Hepatitis C to Assess Sustained Virological Response
NCT04577482 ·Status: COMPLETED
-
Efficacy Study Of Oral Glecaprevir/Pibrentasvir Tablet In Pediatric (12 Years and Older) And Adult Treatment-Naive Participants With Chronic Hepatitis C Genotypes 1 To 6 And Liver Cirrhosis
NCT04352309 ·Status: COMPLETED
-
Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study
NCT02939989 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection
NCT03222583 ·Status: COMPLETED ·Phase: PHASE3
-
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
NCT03067129 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Study of the Effectiveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in Adolescents With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation
NCT04189627 ·Status: COMPLETED
-
Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P
NCT02634008 ·Status: COMPLETED ·Phase: PHASE3
-
Multi-Center, Randomized, Open-Label Study of G/P +/- RBV for NS5A + SOF Previously Treated GT1 HCV Subjects
NCT03092375 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in Women With Hepatitis C With and Without HIV
NCT07040319 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection
NCT04042740 ·Status: COMPLETED ·Phase: PHASE2
-
An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs
NCT03740230 ·Status: COMPLETED
-
Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C in the Russian Federation
NCT03868163 ·Status: COMPLETED
-
36 vs 48 Wks Peg-Intron Plus Ribavirin for HCV Patients Without Rapid Virologic Response But Without HCV RNA at wk 8
NCT01683786 ·Status: UNKNOWN ·Phase: PHASE4
-
Glecaprevir/Pibrentasvir Real-world Study in China
NCT03941821 ·Status: UNKNOWN
-
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Germany (LIFE-C)
NCT02615145 ·Status: COMPLETED
-
The Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in France
NCT02618928 ·Status: COMPLETED
-
Efficacy of PegInterferon-Ribavirin-Boceprevir Therapy in Patients Infected With G1 HCV With Cirrhosis, Awaiting Liver Transplantation
NCT01463956 ·Status: COMPLETED ·Phase: PHASE2
-
Low-Dose Peginterferon and Ribavirin to Treat Chronic Hepatitis C in Patients Infected With HCV Genotype 2 or 3
NCT00056862 ·Status: COMPLETED ·Phase: PHASE4
-
Pegylated Interferon Plus Ribavirin in Treating Older Patients With Chronic Hepatitis C
NCT00629824 ·Status: COMPLETED ·Phase: PHASE4
-
GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype
NCT01384383 ·Status: TERMINATED ·Phase: PHASE2
-
Efficacy and Safety Study of GS-9256 and GS-9190 Alone and in Combination With Ribavirin for 28 Days in Patients With Chronic Hepatitis C Virus Infection
NCT01072695 ·Status: COMPLETED ·Phase: PHASE2