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 |
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.
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
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