A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastrointestinal, Hepatitis, Hepatitis, Hepatitis |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/24/2019 |
| Start Date: | April 28, 2017 |
| End Date: | November 10, 2019 |
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
A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic
HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with
glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response
12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir
compared to the historical SVR12 rates of 12 weeks of treatment with
glecaprevir/pibrentasvir.
HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with
glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response
12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir
compared to the historical SVR12 rates of 12 weeks of treatment with
glecaprevir/pibrentasvir.
Inclusion Criteria:
- Screening laboratory result indicating Hepatitis C Virus (HCV) Genotype (GT) 1-6
infection.
- Positive plasma HCV antibody and HCV RNA viral load greater than or equal to 1000
IU/mL at Screening.
- Treatment-naive to any approved or investigational anti-HCV medication.
- Participant must be documented as cirrhotic, with a Child-Pugh score of less than or
equal to 6.
Exclusion Criteria:
- Female participant who is pregnant, breastfeeding or is considering becoming pregnant
during the study, or for approximately 30 days after the last dose of study drug.
- Any current or historical clinical evidence of decompensated cirrhosis.
- Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti
human immunodeficiency virus antibody (HIV Ab).
- HCV genotype performed by the central laboratory during screening indicating
co-infection with more than one HCV genotype.
- History of suspected or confirmed hepatocellular carcinoma.
We found this trial at
41
sites
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600 Highland Avenue
Madison, Wisconsin 53705
Madison, Wisconsin 53705
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1515 North Flagler Drive
West Palm Beach, Florida 33401
West Palm Beach, Florida 33401
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