Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease
This trial has been completed.
|Conditions||hcv, genotype 1a, genotype 4, chronic kidney disease, hepatitis c, pegifn, ifn|
|Start date||September 2015|
|End date||November 2016|
|Trial size||18 participants|
|Trial identifier||NCT02487199, 2015-002012-33, M15-461|
This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or without dasabuvir in adult genotype 1a or genotype 4 hepatitis C infected participants with severe kidney impairment or end-stage kidney disease.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Adelaide, Australia||Site Reference ID/Investigator# 141184||completed|
|Herston, Australia||Site Reference ID/Investigator# 141183||completed|
|Melbourne, Australia||Site Reference ID/Investigator# 141182||completed|
|Randwick, Australia||Site Reference ID/Investigator# 141181||completed|
|Westmead, Australia||Site Reference ID/Investigator# 141180||completed|
|Auckland, New Zealand||Site Reference ID/Investigator# 141179||completed|
|Barcelona, Spain||Site Reference ID/Investigator# 141178||completed|
|Santiago de Compostela, Spain||Site Reference ID/Investigator# 141177||completed|
|London, United Kingdom||Site Reference ID/Investigator# 140973||completed|
|London, United Kingdom||Site Reference ID/Investigator# 141176||completed|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Treatment with 3-DAA regimen
Treatment with 2-DAA regimen
Percentage of participants with SVR12 in each arm
time frame: 12 weeks after last dose
Number of participants with Adverse Events
time frame: Screening until 30 days after last dose
Percentage of participants with on-treatment virologic failure in each treatment
time frame: Up to 12 weeks after first dose
Percentage of participants with post-treatment relapse within 12 weeks following end of treatment in each arm
time frame: Up to 12 weeks after last dose
Male or female participants from 18 years up to 99 years old.
- Chronic hepatitis C, genotype 1a infection or genotype 4 infection (HCV RNA level greater than 1,000 IU/mL at Screening).
- Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control.
- Chronic kidney disease stage 4 or stage 5.
- Females who are pregnant or breastfeeding
- Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
- HCV genotype performed during screening unable to genotype or co-infection with any other HCV genotype, no mixed genotypes.
- Abnormal laboratory tests
- Current enrollment in another investigational study
- Prior treatment with a direct acting antiviral agent (DAA) containing regimen with the exception of interferon or pegylated interferon with or without ribavirin
- Current treatment with a direct acting antiviral agent (DAA) containing regimen
- Any evidence of liver cirrhosis or liver cancer
|Official title||An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Renal Impairment or End-Stage Renal Disease (RUBY-II)|
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