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Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease

NCT ID: NCT02207088

Last Updated: 2017-11-09

Study Results

Results available

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

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-23

Study Completion Date

2016-12-06

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Hepatitis C Hepatitis C Virus Compensated Cirrhosis Severe Renal Impairment End-stage Renal Disease

Keywords

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Chronic Hepatitis C Hepatitis C End-stage renal disease Hepatitis C Genotype 1 Severe Renal Impairment renal disease Compensated Cirrhosis Renal impairment dialysis Hepatitis C Virus cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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3-DAA (Direct Acting Antivirals) with or without RBV

3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily \[QD\] and dasabuvir 250 mg twice daily \[BID\]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir

Intervention Type DRUG

tablet

dasabuvir

Intervention Type DRUG

tablet

Ribavirin

Intervention Type DRUG

tablet

Interventions

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ombitasvir/paritaprevir/ritonavir

tablet

Intervention Type DRUG

dasabuvir

tablet

Intervention Type DRUG

Ribavirin

tablet

Intervention Type DRUG

Other Intervention Names

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ABT-450/r/ABT-267 Viekira Pak paritaprevir also known as ABT-450 ombitasvir also known as ABT-267 dasabuvir also known as ABT-333 ABT-333 RBV

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Cohen, MD

Role: STUDY_DIRECTOR

AbbVie

Countries

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United States

References

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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)

Pockros PJ, Reddy KR, Mantry PS, Cohen E, Bennett M, Sulkowski MS, Bernstein DE, Cohen DE, Shulman NS, Wang D, Khatri A, Abunimeh M, Podsadecki T, Lawitz E. Efficacy of Direct-Acting Antiviral Combination for Patients With Hepatitis C Virus Genotype 1 Infection and Severe Renal Impairment or End-Stage Renal Disease. Gastroenterology. 2016 Jun;150(7):1590-1598. doi: 10.1053/j.gastro.2016.02.078. Epub 2016 Mar 11.

Reference Type DERIVED
PMID: 26976799 (View on PubMed)

Other Identifiers

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2014-001527-77

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M14-226

Identifier Type: -

Identifier Source: org_study_id