CryoKid is a no-profit, multi-center, single-arm, open-label, pilot study. The study aims to evaluate the tolerability of MK-8742 (Elbasvir) / MK-5172 (Grazoprevir) administrated for 12 weeks without Ribavirin in patients with HCV chronic hepatitis (G1b and G4) and cryoglobulinemic nephropathy.
Study Type
OBSERVATIONAL
Enrollment
45
Administration of MK-8742 (Elbasvir)/MK-5172 (Grazoprevir) for 12 weeks
SVR12
Percentage of participants achieving sustained virologic response 12 weeks after completing treatment (SVR12)
Time frame: march 2018-october 2018
SVR24
Percentage of participants achieving Sustained Virologic Response 24 weeks after ending study treatment (SVR 24)
Time frame: march 2018-december 2018
Clinical response: improvement or disappearance of MC clinical and biochemical stigmata
Clinical response: improvement or disappearance of MC clinical and biochemical stigmata at the EOT, at week 12 and week 24 of follow-up. Improvement of the renal function at week 4, week 8, EOT at week 12 and week 24 of follow-up.
Time frame: march 2018-december 2018
Tolerability: Number of participants experiencing an adverse event (AE)
Tolerability: Number of participants experiencing an adverse event (AE)
Time frame: march 2018-may 2018
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