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
NCT ID: NCT02939989
Last Updated: 2022-05-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
33 participants
INTERVENTIONAL
2016-11-21
2021-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Glecaprevir/Pibrentasvir + SOF + RBV for 12 weeks
Participants without cirrhosis who had non-genotype 3 infection and were naïve to protease inhibitor (PI) and/or nonstructural viral protein 5A inhibitor (NS5Ai) prior to participation in AbbVie HCV parent study received daily treatment with glecaprevir/pibrentasvir (GLE/PIB) 300 mg/120 mg plus sofosbuvir (SOF) 400 mg plus twice-daily weight-based ribavirin (RBV) 600 mg - 1200 mg daily total for 12 weeks.
Sofosbuvir
Tablet for oral administration
Glecaprevir/Pibrentasvir
Coformulated tablet for oral administration
Ribavirin
Tablet for oral administration
Glecaprevir/Pibrentasvir + SOF + RBV for 16 weeks
Participants with genotype 3, and/or compensated cirrhosis, and/or experience with PI and/or NS5Ai prior to participation in Abbvie HCV parent study received daily treatment with GLE/PIB 300 mg/120 mg plus SOF 400 mg plus twice-daily weight-based RBV 600 mg - 1200 mg daily total for 16 weeks.
Sofosbuvir
Tablet for oral administration
Glecaprevir/Pibrentasvir
Coformulated tablet for oral administration
Ribavirin
Tablet for oral administration
Interventions
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Sofosbuvir
Tablet for oral administration
Glecaprevir/Pibrentasvir
Coformulated tablet for oral administration
Ribavirin
Tablet for oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject must have experienced virologic failure during or after treatment with ABT-493/ABT-530 in an AbbVie HCV parent study. Subjects who have experienced virologic failure during or after receiving ombitasvir/paritaprevir/r + dasabuvir (3D), or ombitasvir/paritaprevir/r (2D) in an AbbVie HCV parent study may be enrolled at AbbVie's discretion. Treatment in the parent study must have been completed or discontinued at least 1 month prior to the Screening Visit.
* Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements.
* Cirrhotic subjects must have compensated cirrhosis, (Child-Pugh score of ≤ 6) at Screening and no current or past evidence of Child-Pugh B or C Classification or no clinical history of liver decompensation, including ascites noted on physical exam, hepatic encephalopathy or esophageal variceal bleeding.
* Cirrhotic subjects must have absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound (US), computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or a negative US at Screening.
Exclusion Criteria
* Female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or for 4 months after the last dose of study drug, or as directed per the local RBV label, whichever is more restrictive.
* Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
* Positive test result at Screening for hepatitis B surface antigen (HBsAg).
* Screening laboratory analyses showing calculated creatinine clearance \< 30 mL/min.
* Discontinuation from the AbbVie HCV parent study for reasons other than virologic failure (e.g., non-adherence, lost to follow-up, and/or the occurrence of an adverse event).
* Receipt of any HCV treatment after failing the treatment regimen in the AbbVie HCV parent study.
12 Years
99 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Digestive Health Specialists of the Southeast /ID# 155719
Dothan, Alabama, United States
Ruane Clinical Research Group /ID# 155714
Los Angeles, California, United States
Digestive Disease Associates - Baltimore /ID# 155713
Baltimore, Maryland, United States
Henry Ford Health System /ID# 155720
Detroit, Michigan, United States
University of Buffalo /ID# 155721
Buffalo, New York, United States
Carolinas Center For Liver Dis /ID# 155731
Statesville, North Carolina, United States
Gastro One /ID# 155729
Germantown, Tennessee, United States
TX Liver Inst, Americ Res Corp /ID# 157881
San Antonio, Texas, United States
Royal Brisbane and Women's Hospital /ID# 200944
Herston, Queensland, Australia
The Royal Melbourne Hospital /ID# 155727
Parkville, Victoria, Australia
University of Calgary /ID# 155726
Calgary, Alberta, Canada
Beijing Di Tan Hospital, Capital Medical University /ID# 218496
Beijing, , China
West China Hospital, Sichuan University /ID# 217613
Chengdu, , China
The First Hospital Affiliated to AMU (Southwest Hospital) /ID# 218494
Chongqing, , China
Mengchao Hepatobiliary Hospital of Fujian Medical University /ID# 218495
Fuzhou, , China
Zentru fur HIV und Heaptogastroenterologie /ID# 155592
Düsseldorf, North Rhine-Westphalia, Germany
Asklepios Klinik St. Georg /ID# 155733
Hamburg, , Germany
Auckland City Hospital /ID# 200945
Grafton, Auckland, New Zealand
Dunedin Hospital /ID# 155591
Otago, Otago, New Zealand
Waikato Hospital /ID# 155728
Hamilton, Waikato Region, New Zealand
Medical Company Hepatolog /ID# 214314
Samara, Samara Oblast, Russia
Samsung Medical Center /ID# 214844
Seoul, , South Korea
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 155734
Majadahonda, Madrid, Spain
Duplicate_Karolinska Univ Sjukhuset /ID# 155735
Solna, , Sweden
Inselspital, Universitätsspital Bern /ID# 155716
Bern, , Switzerland
Duplicate_Imperial College Healthcare NHS Trust /ID# 155718
London, , United Kingdom
Countries
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References
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Wyles D, Weiland O, Yao B, Weilert F, Dufour JF, Gordon SC, Stoehr A, Brown A, Mauss S, Zhang Z, Pilot-Matias T, Rodrigues L Jr, Mensa FJ, Poordad F. Retreatment of patients who failed glecaprevir/pibrentasvir treatment for hepatitis C virus infection. J Hepatol. 2019 May;70(5):1019-1023. doi: 10.1016/j.jhep.2019.01.031. Epub 2019 Mar 8. No abstract available.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-002491-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M15-942
Identifier Type: -
Identifier Source: org_study_id
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