A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection



Status:Completed
Conditions:Infectious Disease, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 99
Updated:10/14/2017
Start Date:December 2015
End Date:January 2017

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A Single-Arm, Open-Label, Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally-Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection (EXPEDITION-4)

The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment with
the ABT-493/ABT-530 combination regimen in adults with chronic HCV genotype 1 - 6 infection
and chronic renal impairment.


Inclusion Criteria:

- Chronic hepatitis C virus (HCV) infection

- Screening laboratory results indicating HCV genotype 1 - 6 (GT1 - 6) infection.

- Subject must be HCV treatment-naïve or have failed previous HCV treatment.

- Subjects with underlying chronic renal impairment

- Non-cirrhotic subjects must have documented absence of cirrhosis and subjects with
cirrhosis must have documented compensated cirrhosis.

Exclusion Criteria:

- History of severe, life-threatening or other significant sensitivity to any excipients
of the study drug.

- Female who is pregnant, planning to become pregnant during the study, or
breastfeeding; or male whose partner is pregnant or planning to become pregnant during
the study.

- Recent (within 6 months prior to study drug administration) history of drug or alcohol
abuse that could preclude adherence to the protocol in the opinion of the
investigator.

- Positive test result at Screening for hepatitis B surface antigen (HBsAg) or
anti-human immunodeficiency virus antibody (HIV Ab).

- HCV genotype performed during screening indicating co-infection with more than 1 HCV
genotype.
We found this trial at
9
sites
Germantown, Tennessee 38138
Principal Investigator: Site Reference ID/Investigator# 144360, MD
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Germantown, TN
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Binghamton, New York 13901
Principal Investigator: Site Reference ID/Investigator# 144351, MD
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Binghamton, NY
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Brisbane,
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Bronx, New York
Principal Investigator: Site Reference ID/Investigator# 145926, MD
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Bronx, NY
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Gainesville, Florida 32610
Principal Investigator: Site Reference ID/Investigator# 144354, MD
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Gainesville, FL
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Newark, New Jersey
Principal Investigator: Site Reference ID/Investigator# 144357, MD
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Newark, NJ
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San Antonio, Texas 78224
Principal Investigator: Site Reference ID/Investigator# 145928, MD
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San Antonio, TX
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Seattle, Washington 98105
Principal Investigator: Site Reference ID/Investigator# 145927, MD
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Seattle, WA
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Seattle, WA
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