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

Primary Purpose

Hepatitis C Virus (HCV)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Glecaprevir/Pibrentasvir
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C Virus (HCV) focused on measuring glecaprevir, pibrentasvir, compensated cirrhosis, non-cirrhotic, interferon (IFN), pegylated interferon (pegIFN), ribavirin (RBV), sofosbuvir (SOF), Sustained Virologic Response 12 weeks post dosing (SVR12), Chronic, Genotype 5 or 6 Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research & Education, Inc. /ID# 157042
  • Kaiser Permanente /ID# 157044
  • Zuckerberg San Francisco Gener /ID# 157040
  • Cedars-Sinai Medical Center - West Hollywood /ID# 157045
  • Einstein Medical Center /ID# 157436
  • University of Washington /ID# 157041
  • Nepean Hospital Kingswood /ID# 157027
  • Royal Brisbane and Women's Hospital /ID# 157025
  • Royal Melbourne Hospital /ID# 157024
  • AZ Groeninge /ID# 157029
  • UZ Leuven /ID# 157030
  • University of Calgary /ID# 157031
  • Toronto General Hospital /ID# 157032
  • Hopital Haut-Lévêque /ID# 157035
  • Hopital Beaujon /ID# 157028
  • CHU Estaing /ID# 157034
  • Hopital Saint Antoine /ID# 157036
  • Auckland Clinical Studies Ltd /ID# 157033
  • National University Hospital /ID# 156855
  • Singapore General Hospital /ID# 157037
  • Wits Clinical Research Site /ID# 157038
  • University of Cape Town /ID# 157039
  • National Hospital of Tropical Diseases /ID# 162282
  • Hoa Hao Medic Co. Ltd. /ID# 162283
  • Tropical Diseases Hospital /ID# 162281

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Glecaprevir/Pibrentasvir for 8 Weeks

Glecaprevir/Pibrentasvir for 12 Weeks

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 15, 2016
Last Updated
July 14, 2021
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT02966795
Brief Title
A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 25, 2017 (Actual)
Primary Completion Date
June 6, 2018 (Actual)
Study Completion Date
August 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus (HCV)
Keywords
glecaprevir, pibrentasvir, compensated cirrhosis, non-cirrhotic, interferon (IFN), pegylated interferon (pegIFN), ribavirin (RBV), sofosbuvir (SOF), Sustained Virologic Response 12 weeks post dosing (SVR12), Chronic, Genotype 5 or 6 Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glecaprevir/Pibrentasvir for 8 Weeks
Arm Type
Experimental
Arm Description
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.
Arm Title
Glecaprevir/Pibrentasvir for 12 Weeks
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Glecaprevir/Pibrentasvir
Other Intervention Name(s)
ABT-493/ABT-530, MAVYRET™
Intervention Description
Fixed-dose combination tablets taken orally once a day.
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
Description
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.
Time Frame
12 weeks after last dose of study drug (week 20 or 24 depending on the treatment regimen)
Secondary Outcome Measure Information:
Title
Percentage of Participants With On-treatment HCV Virologic Failure
Description
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.
Time Frame
8 or 12 weeks (depending on the treatment regimen)
Title
Percentage of Participants With Relapse
Description
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.
Time Frame
End of treatment (week 8 or 12 depending on the treatment regimen) through 12 weeks after the end of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Research & Education, Inc. /ID# 157042
City
San Diego
State/Province
California
ZIP/Postal Code
92105
Country
United States
Facility Name
Kaiser Permanente /ID# 157044
City
San Diego
State/Province
California
ZIP/Postal Code
92154
Country
United States
Facility Name
Zuckerberg San Francisco Gener /ID# 157040
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Cedars-Sinai Medical Center - West Hollywood /ID# 157045
City
West Hollywood
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Einstein Medical Center /ID# 157436
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
University of Washington /ID# 157041
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Nepean Hospital Kingswood /ID# 157027
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital /ID# 157025
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Royal Melbourne Hospital /ID# 157024
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
AZ Groeninge /ID# 157029
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
UZ Leuven /ID# 157030
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University of Calgary /ID# 157031
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Toronto General Hospital /ID# 157032
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Hopital Haut-Lévêque /ID# 157035
City
Pessac CEDEX
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
Hopital Beaujon /ID# 157028
City
Clichy
State/Province
Ile-de-France
ZIP/Postal Code
92110
Country
France
Facility Name
CHU Estaing /ID# 157034
City
Clermont Ferrand
ZIP/Postal Code
63100
Country
France
Facility Name
Hopital Saint Antoine /ID# 157036
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Auckland Clinical Studies Ltd /ID# 157033
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
National University Hospital /ID# 156855
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Singapore General Hospital /ID# 157037
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Wits Clinical Research Site /ID# 157038
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
University of Cape Town /ID# 157039
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
National Hospital of Tropical Diseases /ID# 162282
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
Hoa Hao Medic Co. Ltd. /ID# 162283
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Facility Name
Tropical Diseases Hospital /ID# 162281
City
Ho Chi Minh
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Citations:
PubMed Identifier
30393106
Citation
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.
Results Reference
background
PubMed Identifier
35174470
Citation
Brown RS Jr, Collins MA, Strasser SI, Emmett A, Topp AS, Burroughs M, Ferreira R, Feld JJ. Efficacy and Safety of 8- or 12 Weeks of Glecaprevir/Pibrentasvir in Patients with Evidence of Portal Hypertension. Infect Dis Ther. 2022 Apr;11(2):913-924. doi: 10.1007/s40121-022-00599-8. Epub 2022 Feb 17.
Results Reference
derived

Learn more about this trial

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

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