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A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults (GARNET)

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ClinicalTrials.gov Identifier: NCT02582632
Recruitment Status : Completed
First Posted : October 21, 2015
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hepatitis C Infection
Hepatitis C Virus
Interventions Drug: ombitasvir/paritaprevir/ritonavir
Drug: dasabuvir
Enrollment 166
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
Hide Arm/Group Description ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Period Title: Overall Study
Started 166
Completed 165
Not Completed 1
Reason Not Completed
Not Specified             1
Arm/Group Title Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
Hide Arm/Group Description ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Overall Number of Baseline Participants 166
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 166 participants
51.3  (13.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 166 participants
Female
94
  56.6%
Male
72
  43.4%
1.Primary Outcome
Title Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Hide Description SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population: all enrolled participants who received at least 1 dose of study drug. Flanking imputation.
Arm/Group Title Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
Hide Arm/Group Description:
ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Overall Number of Participants Analyzed 166
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97.6
(95.3 to 99.9)
2.Secondary Outcome
Title Percentage of Participants With On-Treatment Virologic Failure During Treatment Period
Hide Description On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the normal approximation to the binomial distribution.
Time Frame Up to 8 weeks while on treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all enrolled participants who received at least 1 dose of study drug.
Arm/Group Title Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
Hide Arm/Group Description:
ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Overall Number of Participants Analyzed 166
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.6
(0.0 to 1.8)
3.Secondary Outcome
Title Percentage of Participants With Post-Treatment Relapse12
Hide Description Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution.
Time Frame Up to 12 weeks after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all enrolled participants who received at least 1 dose of study drug. Participants who did not complete treatment or had no post treatment data available or had HCV RNA ≥ LLOQ at the Final Treatment Visit were not included in the analysis.
Arm/Group Title Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
Hide Arm/Group Description:
ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Overall Number of Participants Analyzed 163
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.2
(0.0 to 2.9)
4.Secondary Outcome
Title Percentage of Female Participants Responding With SVR12
Hide Description SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all enrolled female participants who received at least 1 dose of study drug. Flanking imputation.
Arm/Group Title Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
Hide Arm/Group Description:
ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Overall Number of Participants Analyzed 94
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97.9
(95.0 to 100.0)
5.Secondary Outcome
Title Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12
Hide Description SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.
Time Frame Baseline and 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: all enrolled participants who received at least 1 dose of study drug and with baseline HCV RNA < 6,000,000 IU/mL. Flanking imputation.
Arm/Group Title Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
Hide Arm/Group Description:
ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Overall Number of Participants Analyzed 154
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.1
(95.9 to 100.0)
6.Other Pre-specified Outcome
Title Percentage of Participants Who Achieve SVR12: mITT-GT Population
Hide Description SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
The modified ITT (mITT)-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection. Flanking imputation.
Arm/Group Title Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
Hide Arm/Group Description:
ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Overall Number of Participants Analyzed 163
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.2
(96.1 to 100.0)
7.Other Pre-specified Outcome
Title Percentage of Participants With On-Treatment Virologic Failure During Treatment Period: mITT-GT Population
Hide Description On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the Wilson score method.
Time Frame Up to 8 weeks while on treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection.
Arm/Group Title Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
Hide Arm/Group Description:
ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Overall Number of Participants Analyzed 163
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 2.3)
8.Other Pre-specified Outcome
Title Percentage of Participants With Post-Treatment Relapse12: mITT-GT Population
Hide Description Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution.
Time Frame Up to 12 weeks after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection. Participants who did not complete treatment or had no post treatment data available or had HCV RNA ≥ LLOQ at the Final Treatment Visit were not included in the analysis.
Arm/Group Title Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
Hide Arm/Group Description:
ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Overall Number of Participants Analyzed 161
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.2
(0.0 to 3.0)
9.Other Pre-specified Outcome
Title Percentage of Female Participants Responding With SVR12: mITT-GT Population
Hide Description SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.
Time Frame 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection; female participants. Flanking imputation.
Arm/Group Title Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
Hide Arm/Group Description:
ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Overall Number of Participants Analyzed 93
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97.8
(94.9 to 100.0)
10.Other Pre-specified Outcome
Title Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12: mITT-GT Population
Hide Description SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.
Time Frame Baseline and 12 weeks after the last actual dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection; participants with baseline HCV RNA < 6,000,000 IU/mL. Flanking imputation.
Arm/Group Title Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
Hide Arm/Group Description:
ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
Overall Number of Participants Analyzed 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.7
(96.9 to 100.0)
Time Frame Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (up to 35 days prior to first dose of study drug).
Adverse Event Reporting Description A TEAE is defined as any adverse event from the first dose of study drug to 30 days after the last dose.
 
Arm/Group Title Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
Hide Arm/Group Description ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks
All-Cause Mortality
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
Affected / at Risk (%)
Total   2/166 (1.20%) 
Infections and infestations   
GASTROENTERITIS  1  1/166 (0.60%) 
Nervous system disorders   
SYNCOPE  1  1/166 (0.60%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
Affected / at Risk (%)
Total   70/166 (42.17%) 
Gastrointestinal disorders   
NAUSEA  1  11/166 (6.63%) 
General disorders   
ASTHENIA  1  9/166 (5.42%) 
FATIGUE  1  28/166 (16.87%) 
Infections and infestations   
NASOPHARYNGITIS  1  14/166 (8.43%) 
Nervous system disorders   
HEADACHE  1  35/166 (21.08%) 
Skin and subcutaneous tissue disorders   
PRURITUS  1  14/166 (8.43%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
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: NCT02582632     History of Changes
Other Study ID Numbers: M15-684
2015-003370-33 ( EudraCT Number )
First Submitted: October 20, 2015
First Posted: October 21, 2015
Results First Submitted: November 16, 2017
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017