Clinical Trials

MainTitle

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

This study has been completed
Sponsor
AbbVie


Information provided by (Responsible Party)
AbbVie
ClinicalTrials.gov Identifier
NCT02582632

First received: October 20, 2015
Last updated: November 16, 2017
Last Verified: November 2017
History of Changes
Purpose

Purpose

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).

Condition Intervention Phase
Hepatitis C Infection
Hepatitis C Virus

Drug : ombitasvir/paritaprevir/ritonavir
Drug : dasabuvir
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Further study details as provided by AbbVie:

Primary Outcome Measures

  • Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after the last actual dose of study drug ]
    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 [ Time Frame: Up to 8 weeks while on treatment ]
    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 [ Time Frame: Up to 12 weeks after last dose of study drug ]
    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 [ Time Frame: 12 weeks after the last actual dose of study drug ]
    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 [ Time Frame: Baseline and 12 weeks after the last actual dose of study drug ]
    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.
Other Outcome Measures:
  • Percentage of Participants Who Achieve SVR12: mITT-GT Population [ Time Frame: 12 weeks after the last actual dose of study drug ]
    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 On-Treatment Virologic Failure During Treatment Period: mITT-GT Population [ Time Frame: Up to 8 weeks while on treatment ]
    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.
  • Percentage of Participants With Post-Treatment Relapse12: mITT-GT Population [ Time Frame: Up to 12 weeks after last dose of study drug ]
    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: mITT-GT Population [ Time Frame: 12 weeks after the last actual dose of study drug ]
    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: mITT-GT Population [ Time Frame: Baseline and 12 weeks after the last actual dose of study drug ]
    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.

Enrollment: 166
Study Start Date: November 24, 2015
Study Completion Date: December 1, 2016
Primary Completion Date: August 24, 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
Ombitasvir/Paritaprevir/Ritonavir(25 mg/150 mg/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 8 weeks
Drug: ombitasvir/paritaprevir/ritonavir

Tablet

Other Name:
  • ABT-267/ABT-450/r
  • ombitasvir also known as ABT-267
  • paritaprevir also known as ABT-450

Drug: dasabuvir

Tablet

Other Name: ABT-333
Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 100 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

    1. Chronic HCV infection at Screening.
    2. Screening laboratory result indicating HCV genotype 1b infection.
    3. Treatment-naïve and non-cirrhotic.


Exclusion Criteria:
    1. HCV genotype or subtype other than GT1b.
    2. Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) test.
    3. Any current or past clinical evidence of cirrhosis.
    4. Screening laboratory analyses that shows abnormal results.
    5. Clinically significant abnormalities or co-morbidities, other than HCV infection that
    make the participant an unsuitable candidate for this study.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02582632

Sponsors and Collaborators

AbbVie

Investigators

Study Director: Emily Dumas, PhD AbbVie
More Information

More Information


Responsible Party: AbbVie  
ClinicalTrials.gov Identifier: NCT02582632   History of Changes  
Other Study ID Numbers: M15-684  
  2015-003370-33  
Study First Received: October 20, 2015  
Last Updated: November 16, 2017  

Keywords provided by AbbVie:

Hepatitis C Virus
Interferon-Free
Ribavirin-Free
Hepatitis C
Hepatitis C Genotype 1b

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Ritonavir

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.