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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)

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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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus (HCV)
Intervention Drug: Glecaprevir/Pibrentasvir
Enrollment 84
Recruitment Details This study was conducted in 24 hospitals or clinics in Europe (Belgium, France), Oceania (Australia, New Zealand), North America (Canada, USA), South Africa, and southeast Asia (Singapore, Vietnam). Participants were screened between January 17, 2017, and December 26, 2017.
Pre-assignment Details Enrolled participants with genotype 5 or 6 hepatitis C (HCV) were assigned to treatment with glecaprevir/pibrentasir for either 8 weeks or 12 weeks based on cirrhotic status.
Arm/Group Title Genotype 5-infected Genotype 6-infected
Hide Arm/Group Description Participants with HCV genotype 5 infection received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label. Participants with HCV genotype 6 infection received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
Period Title: Overall Study
Started 23 61
Completed 23 60
Not Completed 0 1
Reason Not Completed
Patient Left the Country             0             1
Arm/Group Title Genotype 5-infected Genotype 6-infected Total
Hide Arm/Group Description Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label. Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label. Total of all reporting groups
Overall Number of Baseline Participants 23 61 84
Hide Baseline Analysis Population Description
All enrolled participants
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 23 participants 61 participants 84 participants
68.0
(24 to 76)
54.0
(30 to 79)
59.0
(24 to 79)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 61 participants 84 participants
< 65 years
8
  34.8%
45
  73.8%
53
  63.1%
≥ 65 years
15
  65.2%
16
  26.2%
31
  36.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 61 participants 84 participants
Female
13
  56.5%
32
  52.5%
45
  53.6%
Male
10
  43.5%
29
  47.5%
39
  46.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 61 participants 84 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
23
 100.0%
61
 100.0%
84
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 61 participants 84 participants
White
21
  91.3%
4
   6.6%
25
  29.8%
Black or African American
1
   4.3%
0
   0.0%
1
   1.2%
Asian
1
   4.3%
56
  91.8%
57
  67.9%
Multi-race
0
   0.0%
1
   1.6%
1
   1.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 23 participants 61 participants 84 participants
New Zealand 1 3 4
Canada 0 13 13
Vietnam 0 12 12
Singapore 0 4 4
Belgium 8 0 8
United States 0 15 15
South Africa 3 1 4
Australia 0 8 8
France 11 5 16
Cirrhosis Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 61 participants 84 participants
Cirrhotic
3
  13.0%
6
   9.8%
9
  10.7%
Non-cirrhotic
20
  87.0%
55
  90.2%
75
  89.3%
Prior HCV Treatment History  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 61 participants 84 participants
Naive
19
  82.6%
57
  93.4%
76
  90.5%
Experienced
4
  17.4%
4
   6.6%
8
   9.5%
HCV Ribonucleic Acid (RNA) Concentration  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 23 participants 61 participants 84 participants
6.52  (0.53) 6.64  (0.74) 6.61  (0.69)
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug. Backward imputation, where applicable, was used to impute missing data. Participants with missing data after backward imputation were counted as non-responders.
Arm/Group Title Genotype 5-infected Genotype 6-infected
Hide Arm/Group Description:
Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
Overall Number of Participants Analyzed 23 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
95.7
(79.0 to 99.2)
98.4
(91.3 to 99.7)
2.Secondary Outcome
Title Percentage of Participants With On-treatment HCV Virologic Failure
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug.
Arm/Group Title Genotype 5-infected Genotype 6-infected
Hide Arm/Group Description:
Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
Overall Number of Participants Analyzed 23 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 14.3)
1.6
(0.3 to 8.7)
3.Secondary Outcome
Title Percentage of Participants With Relapse
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug, with HCV RNA < 15 IU/mL at the end of treatment, at least one post-treatment HCV RNA value, and who completed the assigned treatment.
Arm/Group Title Genotype 5-infected Genotype 6-infected
Hide Arm/Group Description:
Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
Participants received oral glecaprevir/pibrentasir (300 mg/120 mg) once daily with food for either 8 weeks (those without cirrhosis) or 12 weeks (those with compensated cirrhosis), according to label.
Overall Number of Participants Analyzed 23 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
4.3
(0.8 to 21.0)
0.0
(0.0 to 6.0)
Time Frame From first dose of study drug through 30 days after the last dose of study drug; 12 or 16 weeks depending on the treatment regimen.
Adverse Event Reporting Description Adverse events are reported for the overall study population according to the prespecified analysis plan for this study.
 
Arm/Group Title Glecaprevir/Pibrentasvir
Hide Arm/Group Description Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily for 8 or 12 weeks.
All-Cause Mortality
Glecaprevir/Pibrentasvir
Affected / at Risk (%)
Total   0/84 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Glecaprevir/Pibrentasvir
Affected / at Risk (%) # Events
Total   5/84 (5.95%)    
Blood and lymphatic system disorders   
ANAEMIA  1  1/84 (1.19%)  1
Infections and infestations   
ESCHERICHIA PYELONEPHRITIS  1  1/84 (1.19%)  1
GASTRIC ULCER HELICOBACTER  1  1/84 (1.19%)  1
GIARDIASIS  1  1/84 (1.19%)  1
PULMONARY TUBERCULOSIS  1  1/84 (1.19%)  1
VIRAL INFECTION  1  1/84 (1.19%)  1
Psychiatric disorders   
MAJOR DEPRESSION  1  1/84 (1.19%)  1
1
Term from vocabulary, MedDRA (21.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Glecaprevir/Pibrentasvir
Affected / at Risk (%) # Events
Total   26/84 (30.95%)    
Gastrointestinal disorders   
NAUSEA  1  5/84 (5.95%)  5
General disorders   
FATIGUE  1  11/84 (13.10%)  11
Nervous system disorders   
DIZZINESS  1  6/84 (7.14%)  6
HEADACHE  1  11/84 (13.10%)  11
Psychiatric disorders   
INSOMNIA  1  5/84 (5.95%)  5
1
Term from vocabulary, MedDRA (21.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02966795     History of Changes
Other Study ID Numbers: M16-126
2016-003192-22 ( EudraCT Number )
First Submitted: November 15, 2016
First Posted: November 17, 2016
Results First Submitted: June 6, 2019
Results First Posted: July 10, 2019
Last Update Posted: July 10, 2019