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 |
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.
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
Click here to add this to my saved trials
Binghamton, New York 13901
Principal Investigator: Site Reference ID/Investigator# 144351, MD
Click here to add this to my saved trials
Bronx, New York
Principal Investigator: Site Reference ID/Investigator# 145926, MD
Click here to add this to my saved trials
Gainesville, Florida 32610
Principal Investigator: Site Reference ID/Investigator# 144354, MD
Click here to add this to my saved trials
Germantown, Tennessee 38138
Principal Investigator: Site Reference ID/Investigator# 144360, MD
Click here to add this to my saved trials
Newark, New Jersey
Principal Investigator: Site Reference ID/Investigator# 144357, MD
Click here to add this to my saved trials
San Antonio, Texas 78224
Principal Investigator: Site Reference ID/Investigator# 145928, MD
Click here to add this to my saved trials
Seattle, Washington 98105
Principal Investigator: Site Reference ID/Investigator# 145927, MD
Click here to add this to my saved trials
Click here to add this to my saved trials