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Official Title Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.
Phase Phase III
ClinicalTrials.gov NCT02604017
Treatments
Glecaprevir-Pibrentasvir
Glecaprevir-Pibrentasvir
Tradename:MavyretOther Names:GLE-PIBClass:FDA-ApprovedFunding
IndustryAbbVie
References
- Zeuzem S, Foster GR, Wang S, et al. Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection. N Engl J Med. 2018;378:354-69.
Official Title Efficacy of Glecaprevir/Pibrentasvir for 12 Weeks in Patients with HCV Genotype 2, 4, 5, or 6 Infection Without Cirrhosis.
Phase Phase III
ClinicalTrials.gov NCT02640482
Treatments
Glecaprevir-Pibrentasvir
Glecaprevir-Pibrentasvir
Tradename:MavyretOther Names:GLE-PIBClass:FDA-ApprovedFunding
IndustryAbbVie
References
- Asselah T, Kowdley KV, Zadeikis N, et al. Efficacy of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2, 4, 5, or 6 Infection Without Cirrhosis. Clin Gastroenterol Hepatol. 2018;16:417-26.
Official Title Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection.
Phase Phase III
ClinicalTrials.gov NCT02640157
Treatments
Glecaprevir-Pibrentasvir
Glecaprevir-Pibrentasvir
Tradename:MavyretOther Names:GLE-PIBClass:FDA-ApprovedFunding
IndustryAbbVie
References
- Zeuzem S, Foster GR, Wang S, et al. Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection. N Engl J Med. 2018;378:354-69.
Official Title Efficacy of Glecaprevir/Pibrentasvir for 12 Weeks in Patients with HCV Genotype 2, 4, 5, or 6 Infection Without Cirrhosis.
Phase Phase III
ClinicalTrials.gov NCT02636595
Treatments
Glecaprevir-Pibrentasvir
Glecaprevir-Pibrentasvir
Tradename:MavyretOther Names:GLE-PIBClass:FDA-ApprovedFunding
IndustryAbbVie
References
- Asselah T, Kowdley KV, Zadeikis N, et al. Efficacy of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2, 4, 5, or 6 Infection Without Cirrhosis. Clin Gastroenterol Hepatol. 2018;16:417-26.
Official Title Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5,6): an open-label, multicentre, phase 3b trial.
Phase Phase IIIB
ClinicalTrials.gov NCT02966795
Treatments
Glecaprevir-Pibrentasvir
Glecaprevir-Pibrentasvir
Tradename:MavyretOther Names:GLE-PIBClass:FDA-ApprovedFunding
IndustryAbbVie
References
- Asselah T, Lee SS, Yao BB, et al. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5,6): an open-label, multicentre, phase 3b trial. Lancet Gastroenterol Hepatol. 2019;4:45-51.
Official Title Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial.
Phase Phase III
ClinicalTrials.gov NCT02642432
Treatments
Glecaprevir-Pibrentasvir
Glecaprevir-Pibrentasvir
Tradename:MavyretOther Names:GLE-PIBClass:FDA-ApprovedFunding
IndustryAbbVie
References
- Forns X, Lee SS, Valdes J, et al. Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial. Lancet Infect Dis. 2017;17:1062-1068.
Official Title Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients Co-infected With Hepatitis C Virus and Human Immunodeficiency Virus-1: The EXPEDITION-2 Study
Phase Phase III
ClinicalTrials.gov NCT02738138
Treatments
Glecaprevir-Pibrentasvir
Glecaprevir-Pibrentasvir
Tradename:MavyretOther Names:GLE-PIBClass:FDA-ApprovedFunding
IndustryAbbVie
References
- Rockstroh J, Lacombe K, Viani RM, et al. Efficacy and safety of glecaprevir/pibrentasvir in patients co-infected with hepatitis C virus and human immunodeficiency virus-1: the EXPEDITION-2 study. Program and abstracts of the 9th International AIDS Society Conference on HIV Science, 2017; Paris. Abstract 918.[NATAP]
Official Title Glecaprevir and Pibrentasvir in Patients with HCV and Severe Renal Impairment.
Phase Phase III
ClinicalTrials.gov NCT02651194
Treatments
Glecaprevir-Pibrentasvir
Glecaprevir-Pibrentasvir
Tradename:MavyretOther Names:GLE-PIBClass:FDA-ApprovedFunding
IndustryAbbVie
References
- Gane E, Lawitz E, Pugatch D, et al. Glecaprevir and Pibrentasvir in Patients with HCV and Severe Renal Impairment. N Engl J Med. 2017;377:1448-55.
Official Title Efficacy and Safety of glecaprevir/pibrentasvir in Renally Impaired Patients With Chronic HCV Infection
Phase Phase III
ClinicalTrials.gov NCT03069365
Treatments
Glecaprevir-Pibrentasvir
Glecaprevir-Pibrentasvir
Tradename:MavyretOther Names:GLE-PIBClass:FDA-ApprovedFunding
IndustryAbbVie
References
- Lawitz E, Flisiak R, Abunimeh M, et al. Efficacy and safety of glecaprevir/pibrentasvir in renally impaired patients with chronic HCV infection. Liver Int. 2020;40:1032-41.
Official Title A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
Phase Phase IIIB
ClinicalTrials.gov NCT03089944
Treatments
Glecaprevir-Pibrentasvir
Glecaprevir-Pibrentasvir
Tradename:MavyretOther Names:GLE-PIBClass:FDA-ApprovedFunding
IndustryAbbVie
References
- Brown RS Jr, Buti M, Rodrigues L, et al. Glecaprevir/pibrentasvir for 8 weeks in treatment-naïve patients with chronic HCV genotypes 1-6 and compensated cirrhosis: The EXPEDITION-8 trial. J Hepatol. 2020;72:441-9.
Official Title Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease
Treatments
Glecaprevir-Pibrentasvir
Glecaprevir-Pibrentasvir
Tradename:MavyretOther Names:GLE-PIBClass:FDA-ApprovedFunding
IndustryAbbVie
References
- Gane E, Poordad F, Zadeikis N, et al. Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease. Clin Infect Dis. 2019;69:1657-64.
Official Title A Phase 3b, Multi-Center, Randomized, Open-Label, Pragmatic Study of Glecaprevir/Pibrentasvir (G/P) +/- Ribavirin for GT1 Subjects With Chronic Hepatitis C Previously Treated With an NS5A Inhibitor + Sofosbuvir Therapy
Phase Phase III
ClinicalTrials.gov NCT03092375
Treatments
Glecaprevir-Pibrentasvir
Glecaprevir-Pibrentasvir
Tradename:MavyretOther Names:GLE-PIBClass:FDA-ApprovedFunding
IndustryAbbVie
References
- Lok AS, Sulkowski MS, Kort JJ, et al. Efficacy of Glecaprevir and Pibrentasvir in Patients With Genotype 1 Hepatitis C Virus Infection With Treatment Failure After NS5A Inhibitor Plus Sofosbuvir Therapy. Gastroenterology. 2019;157:1506-17.
Official Title An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Glecaprevir-Pibrentasvir in Combination With Sofosbuvir and Ribavirin in Chronic Hepatitis C (HCV) Infected Subjects Who Have Experienced Virologic Failure in AbbVie HCV Clinical Studies (MAGELLAN-3).
Phase Phase IIIB
ClinicalTrials.gov NCT02939989
Treatments
Glecaprevir-Pibrentasvir
Glecaprevir-Pibrentasvir
Tradename:MavyretOther Names:GLE-PIBClass:FDA-ApprovedFunding
IndustryAbbVie
References
- Wyles D, Weiland O, Yao B, et al. Retreatment of patients who failed glecaprevir/pibrentasvir treatment for hepatitis C virus infection. J Hepatol. 2019;70:1019-23.
Official Title Glecaprevir and Pibrentasvir for 12 Weeks for Hepatitis C Virus Genotype 1 Infection and Prior Direct-Acting Antiviral Treatment.
Phase Phase II
Treatments
Glecaprevir-Pibrentasvir
Glecaprevir-Pibrentasvir
Tradename:MavyretOther Names:GLE-PIBClass:FDA-ApprovedFunding
IndustryAbbVie
References
- Poordad F, Felizarta F, Asatryan A, et al. Glecaprevir and pibrentasvir for 12 weeks for hepatitis C virus genotype 1 infection and prior direct-acting antiviral treatment. Hepatology. 2017;66:389-97.
Official Title Glecaprevir/Pibrentasvir in Patients with HCV Genotype 1 or 4 and Prior Direct-acting Antiviral Treatment Failure.
Phase Phase III
ClinicalTrials.gov NCT02446717
Treatments
Glecaprevir-Pibrentasvir
Glecaprevir-Pibrentasvir
Tradename:MavyretOther Names:GLE-PIBClass:FDA-ApprovedFunding
IndustryAbbVie
References
- Poordad F, Pol S, Asatryan A, et al. Glecaprevir/Pibrentasvir in patients with hepatitis C virus genotype 1 or 4 and past direct-acting antiviral treatment failure. Hepatology. 2018;67:1253-60.
Common TitleSURVEYOR-I and SURVEYOR-II Industry
Official Title Glecaprevir and Pibrentasvir Yield High Response Rates in Patients with HCV Genotype 1-6 without Cirrhosis.
Phase Phase II
ClinicalTrials.gov NCT02243280
Treatments
Glecaprevir-Pibrentasvir
Glecaprevir-Pibrentasvir
Tradename:MavyretOther Names:GLE-PIBClass:FDA-ApprovedFunding
IndustryAbbVie
References
- Kwo PY, Poordad F, Asatryan A, et al. Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis. J Hepatol. 2017;67:263-271.
Official Title Glecaprevir/Pibrentasvir for HCV Genotype 3 Patients with Cirrhosis and/or Prior Treatment Experience: A Partially Randomized Phase III Clinical Trial.
Phase Phase III
ClinicalTrials.gov NCT02243293
Treatments
Glecaprevir-Pibrentasvir
Glecaprevir-Pibrentasvir
Tradename:MavyretOther Names:GLE-PIBClass:FDA-ApprovedFunding
IndustryAbbVie
References
- Wyles D, Poordad F, Wang S, et al. Glecaprevir/pibrentasvir for hepatitis C virus genotype 3 patients with cirrhosis and/or prior treatment experience: A partially randomized phase 3 clinical trial. Hepatology. 2018;67:514-23.
Common TitleSURVEYOR-II (Part 4) Industry
Official Title Efficacy of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Patients with HCV Genotype 2, 4, 5, or 6 Infection Without Cirrhosis.
Phase Phase III
ClinicalTrials.gov NCT02243293
Treatments
Glecaprevir-Pibrentasvir
Glecaprevir-Pibrentasvir
Tradename:MavyretOther Names:GLE-PIBClass:FDA-ApprovedFunding
IndustryAbbVie
References
- Asselah T, Kowdley KV, Zadeikis N, et al. Efficacy of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2, 4, 5, or 6 Infection Without Cirrhosis. Clin Gastroenterol Hepatol. 2018;16:417-26.