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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 10, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE November 15, 2016
First Posted Date  ICMJE November 17, 2016
Results First Submitted Date  ICMJE June 6, 2019
Results First Posted Date  ICMJE July 10, 2019
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE January 25, 2017
Actual Primary Completion Date June 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 15, 2016)
Percentage of participants with sustained virologic response 12 weeks post dosing (SVR12) within each genotype (GT; GT5 and GT6) separately across treatment arms [ Time Frame: 12 weeks after last dose of study drug ]
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than the lower limit of quantitation (LLOQ) (less than 15 IU/mL) 12 weeks after the last actual dose of study drug.
Change History Complete list of historical versions of study NCT02966795 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2016)
  • Percentage of Participants With On-treatment HCV Virologic Failure [ Time Frame: During treatment (up to 8 or 12 weeks, treatment arm specific) and at the end of treatment with at least 6 weeks of treatment. ]
    HCV virologic failure defined as:
    • Confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurement of greater than 1 log10 IU/mL above nadir) at any time point during study drug treatment; or
    • Confirmed HCV RNA greater than or equal to 100 IU/mL (defined as 2 consecutive HCV RNA measurements greater than or equal to 100 IU/mL) after HCV RNA less than LLOQ during study drug treatment.
  • Percentage of participants with post-treatment HCV virologic relapse [ Time Frame: At the end of treatment (8 or 12 weeks, treatment arm specific) and 12 weeks after last dose of treatment. ]
    Post-treatment virologic failure (Relapse) is defined as: - Confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) between end of treatment and 12 weeks after the last dose of study drug (up to and including the SVR12 assessment time point), for subjects who completed treatment (defined as study drug duration ≥ 77 days and ≥ 105 days for subjects allocated to the 12 and 16 week durations, respectively) and had HCV RNA < LLOQ at final treatment visit, excluding reinfection, as described below.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C Virus (HCV)
Intervention  ICMJE Drug: Glecaprevir/Pibrentasvir
Fixed-dose combination tablets taken orally once a day.
Other Names:
  • ABT-493/ABT-530
  • MAVYRET™
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Glecaprevir/Pibrentasvir
  • 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.
    Intervention: Drug: Glecaprevir/Pibrentasvir
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2018)
84
Original Estimated Enrollment  ICMJE
 (submitted: November 15, 2016)
80
Actual Study Completion Date  ICMJE August 29, 2018
Actual Primary Completion Date June 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   New Zealand,   Singapore,   South Africa,   United States,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02966795
Other Study ID Numbers  ICMJE M16-126
2016-003192-22 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP