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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 study has been completed.
Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02487199
First received: June 29, 2015
Last updated: April 26, 2017
Last verified: April 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| HCV Genotype 1a Genotype 4 Chronic Kidney Disease Hepatitis C pegIFN IFN | Drug: Ombitasvir/Paritaprevir/Ritonavir Drug: Dasabuvir | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Percentage of participants with SVR12 in each arm [ Time Frame: 12 weeks after last dose ]SVR12 is defined as Hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug.
- Number of participants with Adverse Events [ Time Frame: Screening until 30 days after last dose ]
Secondary Outcome Measures:
- Percentage of participants with on-treatment virologic failure in each treatment [ Time Frame: Up to 12 weeks after first dose ]On-treatment virologic failure is defined as quantifiable hepatitis C virus ribonucleic acid(HCV RNA) throughout the entire treatment period with at least 6 weeks of treatment, confirmed greater than the lower limit of quantification HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase from nadir of at least one log10 in HCV RNA during treatment.
- 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 ]Virologic relapse after treatment is defined as confirmed plasma hepatitis C virus ribonucleic acid (HCV RNA) > the lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.
| Enrollment: | 18 |
| Study Start Date: | September 2015 |
| Study Completion Date: | December 2016 |
| Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Genotype 1a
Treatment with 3-DAA regimen
|
Drug: Ombitasvir/Paritaprevir/Ritonavir Drug: Dasabuvir |
|
Active Comparator: Genotype 4
Treatment with 2-DAA regimen
|
Drug: Ombitasvir/Paritaprevir/Ritonavir |
Eligibility| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02487199
Please refer to this study by its ClinicalTrials.gov identifier: NCT02487199
Locations
| Australia | |
| Site Reference ID/Investigator# 141184 | |
| Adelaide, Australia, 5000 | |
| Site Reference ID/Investigator# 141183 | |
| Herston, Australia, 4029 | |
| Site Reference ID/Investigator# 141182 | |
| Melbourne, Australia, 3004 | |
| Site Reference ID/Investigator# 141181 | |
| Randwick, Australia, 2031 | |
| Site Reference ID/Investigator# 141180 | |
| Westmead, Australia, 2145 | |
| New Zealand | |
| Site Reference ID/Investigator# 141179 | |
| Auckland, New Zealand, 1023 | |
| Spain | |
| Site Reference ID/Investigator# 141178 | |
| Barcelona, Spain, 08003 | |
| Site Reference ID/Investigator# 141177 | |
| Santiago de Compostela, Spain, 15706 | |
| United Kingdom | |
| Site Reference ID/Investigator# 140973 | |
| London, United Kingdom, SE5 9RS | |
| Site Reference ID/Investigator# 141176 | |
| London, United Kingdom, W2 1NY | |
Sponsors and Collaborators
AbbVie
Investigators
| Study Director: | Eric Cohen, MD | AbbVie |
More Information
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT02487199 History of Changes |
| Other Study ID Numbers: |
M15-461 2015-002012-33 ( EudraCT Number ) |
| Study First Received: | June 29, 2015 |
| Last Updated: | April 26, 2017 |
Keywords provided by AbbVie:
|
hepatitis C infection interferon hepatitis C |
treatment experienced severe kidney disease Chronic Kidney Disease |
Additional relevant MeSH terms:
|
Infection Hepatitis Hepatitis A Hepatitis C Kidney Diseases Hepatitis, Chronic Renal Insufficiency, Chronic Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Flaviviridae Infections Urologic Diseases Renal Insufficiency Ritonavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |
ClinicalTrials.gov processed this record on July 14, 2017