Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
This trial has been completed.
|Conditions||chronic hepatitis c, hepatitis c virus, compensated cirrhosis, severe renal impairment, end-stage renal disease|
|Treatments||ombitasvir/paritaprevir/ritonavir, dasabuvir, ribavirin|
|Start date||September 2014|
|End date||December 2016|
|Trial size||63 participants|
|Trial identifier||NCT02207088, 2014-001527-77, M14-226|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Phoenix, AZ||Site Reference ID/Investigator# 128226||completed|
|Coronado, CA||Site Reference ID/Investigator# 141426||completed|
|La Jolla, CA||Site Reference ID/Investigator# 128225||completed|
|San Diego, CA||Site Reference ID/Investigator# 128227||completed|
|San Diego, CA||Site Reference ID/Investigator# 127548||completed|
|Gainesville, FL||Site Reference ID/Investigator# 127554||completed|
|Miami, FL||Site Reference ID/Investigator# 137396||completed|
|Tampa, FL||Site Reference ID/Investigator# 141790||completed|
|Baltimore, MD||Site Reference ID/Investigator# 127557||completed|
|Manhasset, NY||Site Reference ID/Investigator# 127549||completed|
|New York, NY||Site Reference ID/Investigator# 141791||completed|
|Charlotte, NC||Site Reference ID/Investigator# 140975||completed|
|Philadelphia, PA||Site Reference ID/Investigator# 127555||completed|
|Dallas, TX||Site Reference ID/Investigator# 127553||completed|
|Houston, TX||Site Reference ID/Investigator# 127558||completed|
|San Antonio, TX||Site Reference ID/Investigator# 127552||completed|
|Seattle, WA||Site Reference ID/Investigator# 141427||completed|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Percentage of subjects with Sustained Virologic Response 12 weeks post-treatment
time frame: 12 Weeks after the last actual dose of study drug
Percentage of subjects with on-treatment virologic failure
time frame: Up to 12 weeks
Percentage of subjects with post-treatment relapse
time frame: Within 12 weeks after the last dose of study drug
Male or female participants from 18 years up to 99 years old.
- Positive for anti-HCV Ab (Antibody) and HCV RNA >1,000 IU/mL at Screening.
- Screening laboratory result indicating HCV genotype 1 infection.
- 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).
- Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m^2 as estimated by the Modification of Diet in Renal Disease (MDRD) method.
- Women who are pregnant or breastfeeding.
- Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency Virus (HIV Ab).
- 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.
|Official title||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)|
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