A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection
- Conditions
- Hepatitis C Virus (HCV)
- Interventions
- Drug: Glecaprevir/Pibrentasvir
- Registration Number
- NCT02966795
- Lead Sponsor
- AbbVie
- Brief Summary
A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic hepatitis C virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis respectively.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- Screening laboratory result indicating hepatitis C virus (HCV) GT5 or 6 infection.
- Participant has a positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid (RNA) greater than or equal to 1000 IU/mL at Screening Visit.
- Participant must be HCV treatment-naïve (i.e., has never received a single dose of any approved or investigational anti-HCV medication) or treatment-experienced (i.e., has failed prior interferon [IFN] or pegylated interferon [pegIFN] with or without ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN therapy). Prior HCV treatment with any other approved or investigational medications is not allowed. Previous HCV treatment must have been completed greater than or equal to 2 months prior to screening.
- Participant must be documented as having no cirrhosis or compensated cirrhosis.
- 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.
- 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) or anti-human immunodeficiency virus antibody (HIV Ab).
- HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
- History of severe, life-threatening or other significant sensitivity to any excipients of the study drug.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Glecaprevir/Pibrentasvir for 12 Weeks Glecaprevir/Pibrentasvir Participants with hepatitis C virus genotype 5 or 6 and compensated cirrhosis received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for 12 weeks, according to label. Glecaprevir/Pibrentasvir for 8 Weeks Glecaprevir/Pibrentasvir Non-cirrhotic participants with hepatitis C virus genotype 5 or 6 received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for 8 weeks, according to label.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12) 12 weeks after last dose of study drug (week 20 or 24 depending on the treatment regimen) SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last actual dose of study drug.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With On-treatment HCV Virologic Failure 8 or 12 weeks (depending on the treatment regimen) HCV virologic failure was defined as one of the following conditions:
* confirmed HCV RNA ≥ 100 IU/mL after HCV RNA \< 15 IU/mL during the Treatment Period; or confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements \> 1 log10 IU/mL above nadir) at any time point during the Treatment Period; or
* HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment, where the HCV RNA value must be collected on or after Study Drug Day 36 and study drug duration ≥ 36 days.Percentage of Participants With Relapse End of treatment (week 8 or 12 depending on the treatment regimen) through 12 weeks after the end of treatment. Relapse was defined as confirmed HCV RNA ≥ 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA \< 15 IU/mL at the end of treatment and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed.
Trial Locations
- Locations (25)
AZ Groeninge /ID# 157029
🇧🇪Kortrijk, Belgium
Hopital Haut-Lévêque /ID# 157035
🇫🇷Pessac CEDEX, Gironde, France
Nepean Hospital Kingswood /ID# 157027
🇦🇺Kingswood, New South Wales, Australia
Cedars-Sinai Medical Center - West Hollywood /ID# 157045
🇺🇸West Hollywood, California, United States
Singapore General Hospital /ID# 157037
🇸🇬Singapore, Singapore
Auckland Clinical Studies Ltd /ID# 157033
🇳🇿Auckland, New Zealand
Hopital Beaujon /ID# 157028
🇫🇷Clichy, Ile-de-France, France
Einstein Medical Center /ID# 157436
🇺🇸Philadelphia, Pennsylvania, United States
Research & Education, Inc. /ID# 157042
🇺🇸San Diego, California, United States
Toronto General Hospital /ID# 157032
🇨🇦Toronto, Ontario, Canada
Kaiser Permanente /ID# 157044
🇺🇸San Diego, California, United States
University of Washington /ID# 157041
🇺🇸Seattle, Washington, United States
Royal Brisbane and Women's Hospital /ID# 157025
🇦🇺Herston, Queensland, Australia
Wits Clinical Research Site /ID# 157038
🇿🇦Johannesburg, Gauteng, South Africa
University of Cape Town /ID# 157039
🇿🇦Cape Town, Western Cape, South Africa
National Hospital of Tropical Diseases /ID# 162282
🇻🇳Hanoi, Vietnam
Royal Melbourne Hospital /ID# 157024
🇦🇺Parkville, Victoria, Australia
CHU Estaing /ID# 157034
🇫🇷Clermont Ferrand, France
University of Calgary /ID# 157031
🇨🇦Calgary, Alberta, Canada
UZ Leuven /ID# 157030
🇧🇪Leuven, Belgium
Hopital Saint Antoine /ID# 157036
🇫🇷Paris, France
National University Hospital /ID# 156855
🇸🇬Singapore, Singapore
Tropical Diseases Hospital /ID# 162281
🇻🇳Ho Chi Minh, Vietnam
Hoa Hao Medic Co. Ltd. /ID# 162283
🇻🇳Ho Chi Minh, Vietnam
Zuckerberg San Francisco Gener /ID# 157040
🇺🇸San Francisco, California, United States