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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02946034
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : October 4, 2018
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Raymond T. Chung, MD, Massachusetts General Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Kidney Disease Chronic Hepatitis C Drug: Viekira Pak ± ribavirin Drug: Mavyret Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946034


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

Locations
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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
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Principal Investigator: Raymond T Chung, MD Massachusetts General Hospital
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Responsible Party: Raymond T. Chung, MD, Director, Hepatology, Massachusetts General Hospital, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02946034    
Other Study ID Numbers: 2016P001822
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results data will be shared with the study sponsor and publication of data is anticipated.

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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:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Kidney Diseases
Renal Insufficiency, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Urologic Diseases
Renal Insufficiency
Hepatitis, Chronic
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents