Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Gastrointestinal, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - 99
Updated:10/18/2017
Start Date:September 2014
End Date:December 2016

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An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection, With Severe Renal Impairment or End-Stage Renal Disease (RUBY-I)

This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24 week
regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in
HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) <30,
including those on hemodialysis or peritoneal dialysis.


Inclusion Criteria:

1. Positive for anti-HCV Ab (Antibody) and HCV RNA >1,000 IU/mL at Screening.

2. Screening laboratory result indicating HCV genotype 1 infection.

3. Subject has never received antiviral treatment for hepatitis C infection
(treatment-naive subject) or subject has received previous treatment with
peginterferon with or without RBV with non-response (HCV RNA quantifiable at end of
treatment or relapsed after end of treatment).

4. Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m^2 as estimated by the
Modification of Diet in Renal Disease (MDRD) method.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.

2. Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human
Immunodeficiency Virus (HIV Ab).

3. Any current or past clinical evidence of Child-Pugh B or C classification or clinical
history of liver decompensation such as ascites (noted on physical exam), variceal
bleeding, or hepatic encephalopathy.
We found this trial at
17
sites
993
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Miami, FL
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344
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Baltimore, MD
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Charlotte, North Carolina 28207
350
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from 43215
Charlotte, NC
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1953
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Coronado, CA
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910
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Dallas, TX
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711
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Gainesville, FL
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991
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Houston, TX
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1926
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La Jolla, CA
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493
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Manhasset, NY
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481
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New York, NY
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416
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Philadelphia, PA
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1662
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Phoenix, AZ
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1144
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San Antonio, TX
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1951
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San Diego, CA
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1951
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San Diego, CA
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2005
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from 43215
Seattle, WA
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831
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from 43215
Tampa, FL
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