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

Completed · Phase 3

Conditions studied: Hepatitis C Virus (HCV)

In brief

This was a Phase 3b, open-label, non-randomized, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection without liver cirrhosis or with compensated liver cirrhosis and with chronic renal impairment in participants who were either HCV treatment-naïve (TN) or prior treatment-experienced (TE) with interferon (IFN) or pegylated interferon (PegIFN) with or without ribavirin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN.

Key facts

Study ID

NCT03069365

Run by

AbbVie

People needed

101

Starts

2017-03-28

Expected to finish

2018-06-05

Last updated by the study team

2019-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female (of non-childbearing potential or using allowed contraceptive methods) at least 18 years of age time of Screening
• Participant had a positive anti-hepatitis C virus (HCV) antibody (Ab) and plasma HCV ribonucleic acid (RNA) greater than or equal to 1000 IU/mL at the Screening Visit.
• Participant had an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m\^2 as estimated by the Modification of Diet in Renal Disease (MDRD) method at Screening according to the following formula: eGFR (mL/min/1.73 m\^2 ) = 175 × (Serum Creatinine) \^-1.154 × Age\^-0.203 × (0.742 if female) × (1.212 if black), or were dialysis dependent. Subjects requiring dialysis had to have been receiving dialysis for at least 1 month prior to enrollment, and may have been on hemodialysis or peritoneal dialysis.
• Cirrhotic participants only: absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) within 3 months prior to Screening or a negative ultrasound at Screening. Participants who had an ultrasound with results suspicious of HCC followed by a subsequent negative CT or MRI of the liver were eligible for the study.

You may not qualify if…

• Female participants who were pregnant, breastfeeding, or were considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug
• Current hepatitis B virus (HBV) or human immunodeficiency virus (HIV) infection on screening tests, defined as:
• Positive test result at Screening for hepatitis B surface antigen (HBsAg), or;
• HBV deoxyribonucleic acid (DNA) greater than lower limit of quantification (LLOQ) in participants with isolated positive hepatitis B core antibody (HBcAb), (i.e., negative HBsAg and Anti-HBsAg), or;
• Positive anti-HIV antibody (Ab).
• Any current or historical clinical evidence of decompensated cirrhosis, including any current or past evidence of Child-Pugh B or C classification, hepatic encephalopathy or variceal bleeding; radiographic evidence of small ascites; or prior or current empiric use of lactulose/rifaximin for neurologic indications. Prophylactic use of beta blockers was not exclusionary.
• Clinical history of acute renal failure in the 3 months prior to Screening
• History of severe, life-threatening, or other significant sensitivity to any excipients of the study drugs
• Clinically significant abnormalities or co-morbidities, or recent (within 6 months prior to study drug administration) alcohol or drug abuse that could preclude adherence to the protocol in the opinion of the investigator
• Receipt of any investigational or commercially available direct acting anti-HCV agents other than sofosbuvir

Where it is running

• Scripps Clinic /ID# 159116 — La Jolla, California, United States
• Huntington Medical Foundation /ID# 160653 — Pasadena, California, United States
• Tampa General Medical Group /ID# 159115 — Tampa, Florida, United States
• Northwest Louisiana Nephrology /ID# 160652 — Shreveport, Louisiana, United States
• Massachusetts General Hospital /ID# 159114 — Boston, Massachusetts, United States
• North Shore University Hospital /ID# 159108 — New Hyde Park, New York, United States
• Columbia Univ Medical Center /ID# 159112 — New York, New York, United States
• Carolinas Medical Center /ID# 159113 — Charlotte, North Carolina, United States
• University of Pennsylvania /ID# 159117 — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University /ID# 159754 — Philadelphia, Pennsylvania, United States
• TX Liver Inst, Americ Res Corp /ID# 159111 — San Antonio, Texas, United States
• Zeidler Ledcor Centre /ID# 160600 — Edmonton, Alberta, Canada
• Vancouver ID Research and Care /ID# 160598 — Vancouver, British Columbia, Canada
• GIRI Gastrointestinal Research Institute /ID# 160599 — Vancouver, British Columbia, Canada
• Toronto General Hospital /ID# 160601 — Toronto, Ontario, Canada
• Universitatsklinikum Mannheim /ID# 160829 — Mannheim, Baden-Wurttemberg, Germany
• Universitätsklinikum Frankfurt /ID# 160826 — Frankfurt am Main, Hesse, Germany
• Med Hochschule Hanover /ID# 160827 — Hanover, Germany
• Univ Johannes Gutenberg /ID# 160828 — Mainz, Germany
• General Hospital of Athens Laiko /ID# 160725 — Athens, Attica, Greece
• Gen Univ Hosp Alexandroupolis /ID# 160724 — Alexandroupoli, Greece
• General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 160726 — Athens, Greece
• Bioclinic Thessaloniki /ID# 160723 — Thessaloniki, Greece
• A.O.U. Policlinico S.Orsola-Malpighi /ID# 163349 — Bologna, Emilia-Romagna, Italy
• Policlinico A. Gemelli /ID# 160719 — Rome, Lazio, Italy

Full record on ClinicalTrials.gov

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