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A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis (EXPEDITION-8)

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ClinicalTrials.gov Identifier: NCT03089944
Recruitment Status : Completed
First Posted : March 24, 2017
Results First Posted : July 13, 2020
Last Update Posted : July 13, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus (HCV)
Intervention Drug: Glecaprevir/Pibrentasvir
Enrollment 343
Recruitment Details  
Pre-assignment Details A total of 343 participants were enrolled and received ≥ 1 dose of study drug.
Arm/Group Title Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks
Hide Arm/Group Description GLE/PIB 300 mg/120 mg once daily (QD) for 8 weeks.
Period Title: Overall Study
Started 343
Completed 331
Not Completed 12
Reason Not Completed
Lost to Follow-up             8
Withdrew Consent             2
Adverse Event             1
Other             1
Arm/Group Title Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks
Hide Arm/Group Description GLE/PIB 300 mg/120 mg once daily (QD) for 8 weeks.
Overall Number of Baseline Participants 343
Hide Baseline Analysis Population Description
Safety Population: All participants who received at least one dose of study drug were included.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 343 participants
57.61  (10.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 343 participants
Female 126
Male 217
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 343 participants
Hispanic or Latino 43
Not Hispanic or Latino 300
Unknown or Not Reported 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 343 participants
American Indian or Alaska Native 0
Asian 28
Native Hawaiian or Other Pacific Islander 0
Black or African American 28
White 285
More than one race 2
Unknown or Not Reported 0
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Hepatitis C Virus (HCV) Genotype (GT) 1,2,4,5 and 6-infected Participants in the Per Protocol (PP) Population
Hide Description SVR12 was defined as plasma 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 dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the percentage of participants with HCV GT1, GT2, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 94% in the PP population. Efficacy analyses were performed following a fixed-sequence testing procedure to control the type I error rate. The percentage of participants achieving SVR12 was summarized with a 2-sided 95% CI, calculated using the normal approximation to the binomial distribution. If the number of participants who failed to achieve SVR12 rate was less than 5, the Wilson's score method was used to calculate the CI.
Time Frame 12 weeks after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol (PP) Population: All participants who received at least one dose of study drug, with the exception of participants who experienced breakthrough, or prematurely discontinued treatment prior to Week 8, or had no HCV RNA value in the SVR12 visit window or later.
Arm/Group Title Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks
Hide Arm/Group Description:
GLE/PIB 300 mg/120 mg once daily (QD) for 8 weeks.
Overall Number of Participants Analyzed 274
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100
(98.6 to 100.0)
2.Primary Outcome
Title Percentage of Participants With SVR12 in HCV GT 1,2,4,5 and 6-infected Participants in the Intent-To-Treat (ITT) Population
Hide Description SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants with HCV GT1, GT2, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 93% in the ITT population. Primary efficacy analyses were performed following a fixed-sequence testing procedure to control the type I error rate. The percentage of participants achieving SVR12 was summarized with a 2-sided 95% CI, calculated using the normal approximation to the binomial distribution. If the number of participants who failed to achieve SVR12 rate was less than 5, the Wilson's score method was used to calculate the CI.
Time Frame 12 weeks after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population: Participants who received at least one dose of study drug.
Arm/Group Title Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks
Hide Arm/Group Description:
GLE/PIB 300 mg/120 mg once daily (QD) for 8 weeks.
Overall Number of Participants Analyzed 280
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.2
(96.7 to 99.8)
3.Secondary Outcome
Title Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the PP Population
Hide Description SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants with HCV GT1, GT2, GT3, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 94% in the PP population. These efficacy analyses were performed only if success was demonstrated for both primary efficacy analyses, following a fixed-sequence testing procedure.
Time Frame 12 weeks after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
PP population
Arm/Group Title Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks
Hide Arm/Group Description:
GLE/PIB 300 mg/120 mg once daily (QD) for 8 weeks.
Overall Number of Participants Analyzed 335
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
99.7
(98.3 to 99.9)
4.Secondary Outcome
Title Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the ITT Population
Hide Description SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug. Efficacy of the 8-week treatment duration compared to the historical 12-week treatment duration was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants with HCV GT1, GT2, GT3, GT4, GT5, or GT6 infection in the 8 week treatment duration achieving SVR12 was greater than 93% in the ITT population. These efficacy analyses were performed only if success was demonstrated for both primary efficacy analyses, following a fixed-sequence testing procedure.
Time Frame 12 weeks after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks
Hide Arm/Group Description:
GLE/PIB 300 mg/120 mg once daily (QD) for 8 weeks.
Overall Number of Participants Analyzed 343
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97.7
(96.1 to 99.3)
5.Secondary Outcome
Title Percentage of Participants With On-treatment Virologic Failure in the ITT Population
Hide Description On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
Time Frame 8 weeks on treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks
Hide Arm/Group Description:
GLE/PIB 300 mg/120 mg once daily (QD) for 8 weeks.
Overall Number of Participants Analyzed 343
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 1.1)
6.Secondary Outcome
Title Percentage of Participants With Post-treatment Relapse
Hide Description Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned (defined as study drug duration ≥ 52 days for participants assigned to 8 weeks of treatment) and with HCV RNA levels < LLOQ at the end of treatment excluding participants who had been reinfected.
Time Frame Up to 12 weeks after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks
Hide Arm/Group Description:
GLE/PIB 300 mg/120 mg once daily (QD) for 8 weeks.
Overall Number of Participants Analyzed 336
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.3
(0.1 to 1.7)
7.Secondary Outcome
Title Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the PP Population
Hide Description SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug.
Time Frame 12 weeks after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
PP population
Arm/Group Title Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks
Hide Arm/Group Description:
GLE/PIB 300 mg/120 mg once daily (QD) for 8 weeks.
Overall Number of Participants Analyzed 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.4
(91.3 to 99.7)
8.Secondary Outcome
Title Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the ITT Population
Hide Description SVR12 was defined as HCV RNA level less than the LLOQ (less than 15 IU/mL) 12 weeks after the last dose of study drug.
Time Frame 12 weeks after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 Weeks
Hide Arm/Group Description:
GLE/PIB 300 mg/120 mg once daily (QD) for 8 weeks.
Overall Number of Participants Analyzed 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
95.2
(86.9 to 98.4)
Time Frame Treatment emergent adverse events (TEAEs) were defined as any adverse event with an onset date that was on or after the first dose of study drug and no more than 30 days after the last dose of study drug.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Glecaprevir (GLE)/Pibrentasvir (PIB)
Hide Arm/Group Description GLE/PIB 300 mg/120 mg once daily (QD) for 8 weeks.
All-Cause Mortality
Glecaprevir (GLE)/Pibrentasvir (PIB)
Affected / at Risk (%)
Total   0/343 (0.00%)    
Hide Serious Adverse Events
Glecaprevir (GLE)/Pibrentasvir (PIB)
Affected / at Risk (%) # Events
Total   6/343 (1.75%)    
Cardiac disorders   
ATRIAL FIBRILLATION  1  1/343 (0.29%)  1
CARDIAC FAILURE  1  1/343 (0.29%)  1
Gastrointestinal disorders   
DUODENAL ULCER HAEMORRHAGE  1  1/343 (0.29%)  1
General disorders   
OEDEMA PERIPHERAL  1  1/343 (0.29%)  1
Infections and infestations   
BRONCHITIS  1  1/343 (0.29%)  1
PNEUMONIA  1  1/343 (0.29%)  1
PYELONEPHRITIS  1  1/343 (0.29%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
ADENOCARCINOMA GASTRIC  1  1/343 (0.29%)  1
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Glecaprevir (GLE)/Pibrentasvir (PIB)
Affected / at Risk (%) # Events
Total   82/343 (23.91%)    
Gastrointestinal disorders   
NAUSEA  1  19/343 (5.54%)  19
General disorders   
FATIGUE  1  30/343 (8.75%)  30
Nervous system disorders   
HEADACHE  1  28/343 (8.16%)  28
Skin and subcutaneous tissue disorders   
PRURITUS  1  29/343 (8.45%)  29
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
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03089944    
Other Study ID Numbers: M16-135
2016-004967-38 ( EudraCT Number )
First Submitted: March 22, 2017
First Posted: March 24, 2017
Results First Submitted: June 24, 2020
Results First Posted: July 13, 2020
Last Update Posted: July 13, 2020