A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults (GARNET)
Primary Purpose
Hepatitis C Infection, Hepatitis C Virus
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ombitasvir/paritaprevir/ritonavir
dasabuvir
Sponsored by

About this trial
This is an interventional treatment trial for Hepatitis C Infection focused on measuring Hepatitis C Virus, Interferon-Free, Ribavirin-Free, Hepatitis C, Hepatitis C Genotype 1b
Eligibility Criteria
Inclusion Criteria:
- Chronic HCV infection at Screening.
- Screening laboratory result indicating HCV genotype 1b infection.
- Treatment-naïve and non-cirrhotic.
Exclusion Criteria:
- HCV genotype or subtype other than GT1b.
- Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) test.
- Any current or past clinical evidence of cirrhosis.
- Screening laboratory analyses that shows abnormal results.
- Clinically significant abnormalities or co-morbidities, other than HCV infection that make the participant an unsuitable candidate for this study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
Arm Description
Ombitasvir/Paritaprevir/Ritonavir(25 mg/150 mg/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 8 weeks
Outcomes
Primary Outcome Measures
Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
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.
Secondary Outcome Measures
Percentage of Participants With On-Treatment Virologic Failure During Treatment Period
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.
Percentage of Participants With Post-Treatment Relapse12
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.
Percentage of Female Participants Responding With SVR12
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.
Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02582632
Brief Title
A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults
Acronym
GARNET
Official Title
An Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Adults With Genotype 1b Hepatitis C Virus (HCV) Without Cirrhosis (GARNET)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 24, 2015 (undefined)
Primary Completion Date
August 24, 2016 (Actual)
Study Completion Date
December 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b (GT1b) hepatitis C virus (HCV).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Infection, Hepatitis C Virus
Keywords
Hepatitis C Virus, Interferon-Free, Ribavirin-Free, Hepatitis C, Hepatitis C Genotype 1b
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
Arm Type
Experimental
Arm Description
Ombitasvir/Paritaprevir/Ritonavir(25 mg/150 mg/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 8 weeks
Intervention Type
Drug
Intervention Name(s)
ombitasvir/paritaprevir/ritonavir
Other Intervention Name(s)
ABT-267/ABT-450/r, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
dasabuvir
Other Intervention Name(s)
ABT-333
Intervention Description
Tablet
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
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
Secondary Outcome Measure Information:
Title
Percentage of Participants With On-Treatment Virologic Failure During Treatment Period
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
Title
Percentage of Participants With Post-Treatment Relapse12
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
Title
Percentage of Female Participants Responding With SVR12
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
Title
Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12
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
Other Pre-specified Outcome Measures:
Title
Percentage of Participants Who Achieve SVR12: mITT-GT Population
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
Title
Percentage of Participants With On-Treatment Virologic Failure During Treatment Period: mITT-GT Population
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
Title
Percentage of Participants With Post-Treatment Relapse12: mITT-GT Population
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
Title
Percentage of Female Participants Responding With SVR12: mITT-GT Population
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
Title
Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12: mITT-GT Population
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic HCV infection at Screening.
Screening laboratory result indicating HCV genotype 1b infection.
Treatment-naïve and non-cirrhotic.
Exclusion Criteria:
HCV genotype or subtype other than GT1b.
Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) test.
Any current or past clinical evidence of cirrhosis.
Screening laboratory analyses that shows abnormal results.
Clinically significant abnormalities or co-morbidities, other than HCV infection that make the participant an unsuitable candidate for this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Dumas, PhD
Organizational Affiliation
AbbVie
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
28416221
Citation
Welzel TM, Asselah T, Dumas EO, Zeuzem S, Shaw D, Hazzan R, Forns X, Pilot-Matias T, Lu W, Cohen DE, Feld JJ. Ombitasvir, paritaprevir, and ritonavir plus dasabuvir for 8 weeks in previously untreated patients with hepatitis C virus genotype 1b infection without cirrhosis (GARNET): a single-arm, open-label, phase 3b trial. Lancet Gastroenterol Hepatol. 2017 Jul;2(7):494-500. doi: 10.1016/S2468-1253(17)30071-7. Epub 2017 Apr 14.
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A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults
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