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A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis (EXPEDITION-1)

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ClinicalTrials.gov Identifier: NCT02642432
Recruitment Status : Completed
First Posted : December 30, 2015
Results First Posted : September 26, 2017
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following 12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Chronic Hepatitis C Compensated Cirrhosis Drug: ABT-493/ABT-530 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis (EXPEDITION-1)
Actual Study Start Date : December 7, 2015
Primary Completion Date : October 27, 2016
Study Completion Date : February 10, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: ABT-493/ABT-530
ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Drug: ABT-493/ABT-530
Tablet; ABT-493 coformulated with ABT-530
Other Names:
  • ABT-493 also known as glecaprevir
  • ABT-530 also known as pibrentasvir
  • MAVYRET



Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after the last actual dose of study drug ]
    SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.


Secondary Outcome Measures :
  1. Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Treatment Weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment ]
    On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.

  2. Percentage of Participants With Post-treatment Relapse [ Time Frame: From the end of treatment through 12 weeks after the last dose of study drug ]
    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 with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Screening laboratory result indicating hepatitis C virus (HCV) Genotype 1, 2, 4, 5 or 6 (GT1,2,4,5,6) infection
  • Chronic HCV infection
  • Subject must be HCV treatment-naïve or have failed prior HCV treatment
  • Subject must have documented compensated cirrhosis and no current or past clinical evidence of decompensated liver disease

Exclusion Criteria:

  • Positive test result at screening for Hepatitis B surface antigen or anti-human immunodeficiency virus (anti-HIV) antibody
  • HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype
  • Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642432


Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc AbbVie

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02642432     History of Changes
Other Study ID Numbers: M14-172
2015-003797-32 ( EudraCT Number )
First Posted: December 30, 2015    Key Record Dates
Results First Posted: September 26, 2017
Last Update Posted: October 26, 2017
Last Verified: September 2017

Keywords provided by AbbVie:
HCV Genotype 1
HCV Genotype 4
HCV Genotype 2
Cirrhotic
Interferon-Free
Compensated Cirrhosis
HCV Genotype 5
Hepatitis C
HCV Genotype 6

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Fibrosis
Liver Cirrhosis
Hepatitis C, Chronic
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes