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

Description

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

Study Start Date

February, 01 2017

Estimated Completion Date

December 2019

Interventions

  • Drug: Viekira Pak ± ribavirin

Study ID

Massachusetts General Hospital -- 2016P001822

Status

Unknown

Trial ID

NCT02946034

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

24

Sponsor

Massachusetts General Hospital

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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (5)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Donald Chute BA None LiverResearchGroup@partners.org
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Donald Chute BA None LiverResearchGroup@partners.org
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Donald Chute BA None LiverResearchGroup@partners.org
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Donald Chute BA None LiverResearchGroup@partners.org
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Donald Chute BA None LiverResearchGroup@partners.org

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