Phase 4 N=10 Treatment

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

Chronic Kidney Disease · Chronic Hepatitis C

Bottom Line

View on ClinicalTrials.gov: NCT02946034 ↗

Enrolled (actual)

Serious AEs

50.0%

Results posted

Nov 2021

Primary outcome: Primary: Average Change in Urine Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment — -0.05 ng/g

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Viekira Pak ± ribavirin (Drug); Mavyret (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Sep 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Average Change in Urine Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment	-0.05	—
PRIMARY Average Change in Urine Interleukin (IL)-6 From Baseline to Post-treatment	5.73	—
PRIMARY Average Change in Plasma Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment	6.67	—
PRIMARY Average Change in Plasma Interferon Gamma-induced Protein 10 (IP-10) From Baseline to Post-treatment	-394.57	—
PRIMARY Average Change in Plasma Interferon (IFN)-Gamma From Baseline to Post-treatment	2.01	—
PRIMARY Average Change in Plasma Interleukin (IL)-6 From Baseline to Post-treatment	-3.94	—
SECONDARY Number of Patients Who Suffered Adverse Events Related to Study Drug (Safety and Tolerability)	4	—
SECONDARY Number of Patients Who Had Sustained Virologic Response at 12-weeks (SVR12) Post-treatment (Efficacy of Treatment)	8	—

Summary

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02946034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.