Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified October 2018 by Raymond T. Chung, MD, Massachusetts General Hospital

Sponsor
Massachusetts General Hospital

Collaborator
AbbVie

Information provided by (Responsible Party)
Raymond T. Chung, MD, Massachusetts General Hospital

ClinicalTrials.gov Identifier
NCT02946034

First received: October 21, 2016
Last updated: October 2, 2018
Last Verified: October 2018
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
Chronic Kidney Disease
Chronic Hepatitis C

Drug : Viekira Pak ± ribavirin
Drug : Mavyret
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety, Efficacy, and Changes in Traditional and Novel Biomarkers of Kidney Function in Patients With Hepatitis C and Advanced Chronic Kidney Disease Treated With Abbvie Viekira Pak or Mavyret Regimen

Further study details as provided by Raymond T. Chung, MD, Massachusetts General Hospital:

Primary Outcome Measures

  • Reduction in biomarkers of CKD progression [ Time Frame: 52 Weeks ]
    Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.
Secondary Outcome Measures:
  • Safety and Tolerability of Viekira Pak treatment in CKD patients [ Time Frame: 12 weeks ]
    Safety and tolerability of Viekira Pak treatment in CKD patients will be assessed by composite outcome measure consisting of absolute values and changes from baseline in: adverse events, clinical safety laboratory tests and vital signs
  • Efficacy of Viekira Pak treatment in CKD patients [ Time Frame: 24 weeks ]
    Efficacy will be determined by negative HCV RNA viral load measured during the 12 week treatment period as well as 12 weeks after the last dose.
  • Effect on patient quality of life [ Time Frame: 52 Weeks ]
    Quality of life will be assessed by on treatment and post-treatment patient fatigue questionnaire (FACIT-F) scoring.
  • Effect on patient quality of life [ Time Frame: 52 Weeks ]
    Quality of life will be assessed by on treatment and post-treatment patient physical and mental health summary scores from the SF-36 questionnaire.

Estimated Enrollment: 24
Study Start Date: February 1, 2017
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Treatment 1
12 week therapy with Viekira Pak ± ribavirin
Drug: Viekira Pak ± ribavirin

12 weeks treatment with AbbVie Viekira Pak ± ribavirin

Other Name: AbbVie 3D regimen
Experimental: Treatment 2
12 week therapy with Mavyret
Drug: Mavyret

12 weeks treatment with AbbVie Mavyret

Detailed Description:

The objective of arm 1 of this study is to evaluate the effect of paritaprevir/ritonavir, ombitasvir, dasabuvir (referred to as Viekira Pak) ± ribavirin 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.
The objective of arm 2 is to evaluate 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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

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: NCT02946034

Contacts

Contact:   Raymond T Chung, MD 6177247562 rchung@partners.org
Contact:   Jenna L Gustafson, MS 6177243836 JLGustafson@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Donald Chute, BA    LiverResearchGroup@partners.org
Principal Investigator: Raymond T Chung, MD
Sub-Investigator: Meghan E Sise, MD

Sponsors and Collaborators

Massachusetts General Hospital
AbbVie

Investigators

Principal Investigator: Raymond T Chung, MD Massachusetts General Hospital
More Information

More Information


Responsible Party: Raymond T. Chung, MD, Director, Hepatology, Massachusetts General Hospital, Massachusetts General Hospital  
ClinicalTrials.gov Identifier: NCT02946034   History of Changes  
Other Study ID Numbers: 2016P001822  
Study First Received: October 21, 2016  
Last Updated: October 2, 2018  
Individual Participant Data    
Plan to Share IPD: Yes  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  
Product Manufactured in and Exported from the U.S.: No  

Keywords provided by Raymond T. Chung, MD, Massachusetts General Hospital:

CKD
HCV

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Kidney Diseases
Renal Insufficiency, Chronic
Ribavirin

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.