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NCT02642432 Clinical Trial

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

Chronic Hepatitis C Clinical Trial

— EXPEDITION-1  

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02642432
Other study ID # M14-172
Secondary ID 2015-003797-32
Status Completed
Phase Phase 3
First received
Last updated
Start date December 7, 2015
Est. completion date February 10, 2017

Study information
Verified date July 2021
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 146
Est. completion date February 10, 2017
Est. primary completion date October 27, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ABT-493/ABT-530
Tablet; ABT-493 coformulated with ABT-530

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

References & Publications (1)

Forns X, Lee SS, Valdes J, Lens S, Ghalib R, Aguilar H, Felizarta F, Hassanein T, Hinrichsen H, Rincon D, Morillas R, Zeuzem S, Horsmans Y, Nelson DR, Yu Y, Krishnan P, Lin CW, Kort JJ, Mensa FJ. Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial. Lancet Infect Dis. 2017 Oct;17(10):1062-1068. doi: 10.1016/S1473-3099(17)30496-6. Epub 2017 Aug 14. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [ 12 weeks after the last actual dose of study drug
Secondary Percentage of Participants With On-treatment Virologic Failure 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. Treatment Weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment
Secondary Percentage of Participants With Post-treatment Relapse 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. From the end of treatment through 12 weeks after the last dose of study drug
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