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
• 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
• 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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Communicable Diseases
• Compensated Cirrhosis
• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection
• Liver Cirrhosis

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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