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

Completed · Phase 3

Conditions studied: Hepatitis C Virus Infection

In brief

The purpose of this study was to evaluate the efficacy and safety of co-administration of glecaprevir (ABT-493)/pibrentasvir (ABT 530) plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV) genotype (GT) 1 - 6-infected participants (including non-cirrhotic, or cirrhotic with compensated cirrhosis participants) who had experienced virologic failure in an AbbVie parent clinical study.

Key facts

Study ID

NCT02939989

Run by

AbbVie

People needed

33

Starts

2016-11-21

Expected to finish

2021-07-30

Last updated by the study team

2022-05-04

Who can join

Age: 12 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects must be adults (18 years of age or older) or adolescents (12 to less than 18 years of age weighing at least 35 kg).
• 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.

You may not qualify if…

• History of severe, life-threatening or other clinically significant sensitivity to any study drug or drug component.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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