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

Use our guide to learn which trials are right for you!

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
Binghamton, New York 13901
Principal Investigator: Site Reference ID/Investigator# 144351, MD
2270
mi
from 98109
Binghamton, NY
Click here to add this to my saved trials
7361
mi
from 98109
Brisbane,
Click here to add this to my saved trials
Bronx, New York
Principal Investigator: Site Reference ID/Investigator# 145926, MD
2402
mi
from 98109
Bronx, NY
Click here to add this to my saved trials
Gainesville, Florida 32610
Principal Investigator: Site Reference ID/Investigator# 144354, MD
2450
mi
from 98109
Gainesville, FL
Click here to add this to my saved trials
Germantown, Tennessee 38138
Principal Investigator: Site Reference ID/Investigator# 144360, MD
1877
mi
from 98109
Germantown, TN
Click here to add this to my saved trials
Newark, New Jersey
Principal Investigator: Site Reference ID/Investigator# 144357, MD
2393
mi
from 98109
Newark, NJ
Click here to add this to my saved trials
San Antonio, Texas 78224
Principal Investigator: Site Reference ID/Investigator# 145928, MD
1790
mi
from 98109
San Antonio, TX
Click here to add this to my saved trials
Seattle, Washington 98105
Principal Investigator: Site Reference ID/Investigator# 145927, MD
2
mi
from 98109
Seattle, WA
Click here to add this to my saved trials
2
mi
from 98109
Seattle, WA
Click here to add this to my saved trials