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

• Status: Completed
• Trial end date: 2020-09-16
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: AbbVie
• Treatments: Ribavirin

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