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Viekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and Hepatitis C

NCT ID: NCT02946034

Last Updated: 2021-11-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2020-09-16

Brief Summary

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Open-label experimental trial of 12 weeks of Viekira Pak treatment ± ribavirin or Mavyret for adults with chronic kidney disease and hepatitis C.

Detailed Description

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The objective of this study is to evaluate the effect of paritaprevir/ritonavir, ombitasvir, dasabuvir (referred to as Viekira Pak) ± ribavirin or Glecaprevir / Pibrentasvir (referred to as Mavyret) for adults with advanced CKD with an estimated glomerular filtration rate (eGFR) less than 45ml/min that are infected with hepatitis C virus (HCV) genotype 1 and to determine the effect of treatment on traditional and novel markers of kidney function and cardiovascular disease risk in patients with advanced CKD. During the course of this prospective, single arm treatment trial, we will measure currently accepted markers of kidney function and novel biomarkers of CKD progression to determine if they improve with eradication of HCV.

Conditions

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Chronic Kidney Disease Chronic Hepatitis C

Keywords

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CKD HCV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This a single-arm study. Initially, Viekira Pak was available through Abbvie. However, once Mavyret became available, it supplanted Viekira Pak as the study medication.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Viekira Pak ± ribavirin or Mavyret

12 week therapy with Viekira Pak ± ribavirin

8 or 12 week therapy with Mavyret

Group Type EXPERIMENTAL

Viekira Pak ± ribavirin

Intervention Type DRUG

12 weeks treatment with AbbVie Viekira Pak ± ribavirin

Mavyret

Intervention Type DRUG

8 or 12 weeks treatment with AbbVie Mavyret

Interventions

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Viekira Pak ± ribavirin

12 weeks treatment with AbbVie Viekira Pak ± ribavirin

Intervention Type DRUG

Mavyret

8 or 12 weeks treatment with AbbVie Mavyret

Intervention Type DRUG

Other Intervention Names

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AbbVie 3D regimen

Eligibility Criteria

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Inclusion Criteria

1. Male or female ≥ 18 year of age
2. HCV genotype 1 ≥ 1000 IU/mL
3. 6\. Estimated glomerular filtration rate 15-45mL/min/1.73m2 as estimated by CKD-Epi equation

Exclusion Criteria

1. Pregnant or lactating females
2. Uncontrolled depression or psychiatric disease
3. History or presence of any form of cancer within 3 years of enrollment
4. Experiencing life-threatening cryoglobulinemic vasculitis requiring initiation of rituximab, steroids or plasmapheresis.
5. Uncontrolled cardiovascular or pulmonary disease
6. Experiencing symptoms attributed to uremia
7. Anticipated need to begin renal replacement therapy in the next 6 months
8. History of kidney transplant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Raymond Chung

Director, Hepatology, Massachusetts General Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raymond T Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2016P001822

Identifier Type: -

Identifier Source: org_study_id