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)

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

Sponsors

Lead sponsor: AbbVie

Source 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.

Overall Status Completed
Start Date December 7, 2015
Completion Date February 10, 2017
Primary Completion Date October 27, 2016
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) 12 weeks after the last actual dose of study drug
Secondary Outcome
Measure Time Frame
Percentage of Participants With On-treatment Virologic Failure Treatment Weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment
Percentage of Participants With Post-treatment Relapse From the end of treatment through 12 weeks after the last dose of study drug
Enrollment 146
Condition
Intervention

Intervention type: Drug

Intervention name: ABT-493/ABT-530

Description: Tablet; ABT-493 coformulated with ABT-530

Arm group label: ABT-493/ABT-530

Eligibility

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
AbbVie Inc Study Director AbbVie
Verification Date

September 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: ABT-493/ABT-530

Arm group type: Experimental

Description: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.

Acronym EXPEDITION-1
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov