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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: May 1, 2017
Last Verified: May 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 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 ]
    Hepatitis c virus ribonucleic acid (HCV RNA) levels less than the lower limit of quantification.
Secondary Outcome Measures:
  • Percentage of participants with virologic failure during treatment [ Time Frame: Up to 8 weeks while on treatment ]
    The percentage of participants with confirmed >=1 log10 IU/mL increase from nadir in HCV RNA at any time point during treatment or with confirmed, quantifiable HCV RNA among participants with previous unquantifiable HCV RNA during treatment; or failure to suppress during treatment with at least 6 weeks of treatment.
  • Percentage of participants with post-treatment relapse [ Time Frame: Up to 12 weeks after last dose of study drug ]
    The percentage of participants with confirmed, quantifiable HCV RNA among participants with previous unquantifiable HCV RNA at the end of treatment.
  • Percentage of female participants who achieve sustained virologic response 12 (SVR12) weeks post-treatment [ Time Frame: 12 weeks after the last actual dose of study drug ]
    HCV RNA levels less than the lower limit of quantification
  • Percentage of participants with low baseline viral load who achieve sustained virologic response 12 (SVR12) weeks post-treatment [ Time Frame: Baseline and 12 weeks after the last actual dose of study drug ]
    HCV RNA levels less than the lower limit of quantification.

Enrollment: 166
Study Start Date: November 2015
Study Completion Date: December 2016
Primary Completion Date: December 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
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

Locations

Australia
Site Reference ID/Investigator# 145473
Adelaide, Australia, 5000
Site Reference ID/Investigator# 145471
Westmead, Australia, 2145
Site Reference ID/Investigator# 145472
Woolloongabba, Brisbane, Australia, 4102
Canada
Site Reference ID/Investigator# 145475
Toronto, Canada, M5G 2C4
Site Reference ID/Investigator# 145474
Vancouver, Canada, V6Z 2C7
Site Reference ID/Investigator# 145477
Winnipeg, Canada, R3E 3P4
France
Site Reference ID/Investigator# 145909
Clichy, France, 92110
Site Reference ID/Investigator# 145488
Limoges, France, 87042
Site Reference ID/Investigator# 145487
Marseilles, France, 13285
Germany
Site Reference ID/Investigator# 145491
Frankfurt am Main, Germany, 60590
Site Reference ID/Investigator# 145625
Kiel, Germany, 24146
Israel
Site Reference ID/Investigator# 145347
Afula, Israel, 1834111
Site Reference ID/Investigator# 145358
Petah Tikva, Israel, 49414 92
Italy
Site Reference ID/Investigator# 145536
Rome, Italy, 00186
Site Reference ID/Investigator# 145535
Rozzano, Italy, 20089
Spain
Site Reference ID/Investigator# 145547
Barcelona, Spain, 08028
Site Reference ID/Investigator# 145548
Sevilla, Spain, 41013
United Kingdom
Site Reference ID/Investigator# 145551
Nottingham, United Kingdom, NG7 2UH
Site Reference ID/Investigator# 145550
Plymouth, United Kingdom, PL6 8DH
Site Reference ID/Investigator# 145549
Portsmouth, Hampshire, United Kingdom, PO6 3LY

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: May 1, 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 October 16, 2017
This information is provided by ClinicalTrials.gov.