MedDataX Logo

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

NCT ID: NCT02487199

Last Updated: 2017-12-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-12-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or without dasabuvir in adults with hepatitis C virus (HCV) genotype 1a (GT1a) or genotype 4 (GT4) infection and with severe kidney impairment or end-stage kidney disease.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis C Virus (HCV)

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

hepatitis C infection hepatitis C severe kidney disease chronic kidney disease Genotype 1a Genotype 4 treatment experienced interferon IFN pegIFN

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HCV GT1a (3-DAA)

Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks.

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir and dasabuvir

Intervention Type DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

HCV GT4 (2-DAA)

Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\]) for 12 weeks.

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir

Intervention Type DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ombitasvir/paritaprevir/ritonavir and dasabuvir

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Intervention Type DRUG

ombitasvir/paritaprevir/ritonavir

Tablet; ombitasvir coformulated with paritaprevir and ritonavir

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Viekira Pak, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267, dasabuvir also known as ABT-333 Technivie, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Chronic hepatitis C virus (HCV) genotype 1a (GT1a) infection or genotype 4 (GT4) 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 test result for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

AbbVie Inc

Role: STUDY_DIRECTOR

AbbVie

Countries

Review the countries where the study has at least one active or historical site.

Australia New Zealand Spain United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Shuster DL, Menon RM, Ding B, Khatri A, Li H, Cohen E, Jewett M, Cohen DE, Zha J. Effects of chronic kidney disease stage 4, end-stage renal disease, or dialysis on the plasma concentrations of ombitasvir, paritaprevir, ritonavir, and dasabuvir in patients with chronic HCV infection: pharmacokinetic analysis of the phase 3 RUBY-I and RUBY-II trials. Eur J Clin Pharmacol. 2019 Feb;75(2):207-216. doi: 10.1007/s00228-018-2566-6. Epub 2018 Oct 5.

Reference Type DERIVED
PMID: 30291369 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://rxabbvie.com

Related Info

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015-002012-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M15-461

Identifier Type: -

Identifier Source: org_study_id