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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 July 2021 |
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Main ID: |
NCT02642432 |
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Date of registration:
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28/12/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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) |
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Date of first enrolment:
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December 7, 2015 |
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Target sample size:
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146 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02642432 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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Canada
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Germany
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South Africa
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Spain
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United States
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Contacts
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Name:
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AbbVie Inc |
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Address:
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Telephone:
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Email:
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Affiliation:
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AbbVie |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Hepatitis C
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Compensated Cirrhosis
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Hepatitis C Virus Infection
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Intervention(s)
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Drug: ABT-493/ABT-530
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Primary Outcome(s)
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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
[Time Frame: 12 weeks after the last actual dose of study drug]
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Secondary Outcome(s)
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Percentage of Participants With Post-treatment Relapse
[Time Frame: From the end of treatment through 12 weeks after the last dose of study drug]
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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]
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Secondary ID(s)
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2015-003797-32
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M14-172
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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