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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02966795
Recruitment Status : Completed
First Posted : November 17, 2016
Results First Posted : July 10, 2019
Last Update Posted : July 30, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus (HCV) Drug: Glecaprevir/Pibrentasvir Phase 3

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 25, 2017
Actual Primary Completion Date : June 6, 2018
Actual Study Completion Date : August 29, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Glecaprevir/Pibrentasvir for 8 Weeks
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.
 Drug: Glecaprevir/Pibrentasvir
Fixed-dose combination tablets taken orally once a day.
Other Names:
  • ABT-493/ABT-530
  • MAVYRET™
Experimental: Glecaprevir/Pibrentasvir for 12 Weeks
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.
 Drug: Glecaprevir/Pibrentasvir
Fixed-dose combination tablets taken orally once a day.
Other Names:
  • ABT-493/ABT-530
  • MAVYRET™


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12) [ Time Frame: 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 :
  1. Percentage of Participants With On-treatment HCV Virologic Failure [ Time Frame: 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.

  2. Percentage of Participants With Relapse [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966795


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:
Study Protocol  [PDF] July 28, 2017
Statistical Analysis Plan  [PDF] May 15, 2018

More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02966795    
Other Study ID Numbers: M16-126
2016-003192-22 ( EudraCT Number )
First Posted: November 17, 2016    Key Record Dates
Results First Posted: July 10, 2019
Last Update Posted: July 30, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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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
Keywords provided by AbbVie:
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
Additional relevant MeSH terms:
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Infections
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepatitis, Chronic
Chronic Disease
Disease Attributes
Pathologic Processes