A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection

Hepatitis C Virus (HCV) Clinical Trial

— ENDURANCE-5 6  

Official title:

A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02966795
• Other study ID #: M16-126
• Secondary ID: 2016-003192-22
• Status: Completed
• Phase: Phase 3
• Start date: January 25, 2017
• Est. completion date: August 29, 2018

Study information

• Verified date: July 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: August 29, 2018
• Est. primary completion date: June 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

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.

• 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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus (HCV)
• Hepatitis C, Chronic
• Infection

Intervention

Drug:
• Glecaprevir/Pibrentasvir
Fixed-dose combination tablets taken orally once a day.

Locations

Country	Name	City	State
Australia	Royal Brisbane and Women's Hospital /ID# 157025	Herston	Queensland
Australia	Nepean Hospital Kingswood /ID# 157027	Kingswood	New South Wales
Australia	Royal Melbourne Hospital /ID# 157024	Parkville	Victoria
Belgium	AZ Groeninge /ID# 157029	Kortrijk
Belgium	UZ Leuven /ID# 157030	Leuven
Canada	University of Calgary /ID# 157031	Calgary	Alberta
Canada	Toronto General Hospital /ID# 157032	Toronto	Ontario
France	CHU Estaing /ID# 157034	Clermont Ferrand
France	Hopital Beaujon /ID# 157028	Clichy	Ile-de-France
France	Hopital Saint Antoine /ID# 157036	Paris
France	Hopital Haut-Lévêque /ID# 157035	Pessac CEDEX	Gironde
New Zealand	Auckland Clinical Studies Ltd /ID# 157033	Auckland
Singapore	National University Hospital /ID# 156855	Singapore
Singapore	Singapore General Hospital /ID# 157037	Singapore
South Africa	University of Cape Town /ID# 157039	Cape Town	Western Cape
South Africa	Wits Clinical Research Site /ID# 157038	Johannesburg	Gauteng
United States	Einstein Medical Center /ID# 157436	Philadelphia	Pennsylvania
United States	Kaiser Permanente /ID# 157044	San Diego	California
United States	Research & Education, Inc. /ID# 157042	San Diego	California
United States	Zuckerberg San Francisco Gener /ID# 157040	San Francisco	California
United States	University of Washington /ID# 157041	Seattle	Washington
United States	Cedars-Sinai Medical Center - West Hollywood /ID# 157045	West Hollywood	California
Vietnam	National Hospital of Tropical Diseases /ID# 162282	Hanoi
Vietnam	Hoa Hao Medic Co. Ltd. /ID# 162283	Ho Chi Minh
Vietnam	Tropical Diseases Hospital /ID# 162281	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Vietnam,  Australia,  Belgium,  Canada,  France,  New Zealand,  Singapore,  South Africa, 

References & Publications (1)

Asselah T, Lee SS, Yao BB, Nguyen T, Wong F, Mahomed A, Lim SG, Abergel A, Sasadeusz J, Gane E, Zadeikis N, Schnell G, Zhang Z, Porcalla A, Mensa FJ, Nguyen K. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5,6): an open-label, multicentre, phase 3b trial. Lancet Gastroenterol Hepatol. 2019 Jan;4(1):45-51. doi: 10.1016/S2468-1253(18)30341-8. Epub 2018 Nov 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12)	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.	12 weeks after last dose of study drug (week 20 or 24 depending on the treatment regimen)
Secondary	Percentage of Participants With On-treatment HCV Virologic Failure	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.	8 or 12 weeks (depending on the treatment regimen)
Secondary	Percentage of Participants With Relapse	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.	End of treatment (week 8 or 12 depending on the treatment regimen) through 12 weeks after the end of treatment.