Status:
UNKNOWN
Grazoprevir and Elbasvir Without Ribavirin for 12 Weeks in Patients With HCV-related Cryoglobulinemic Nephropathy
Lead Sponsor:
University of Florence
Conditions:
Hepatitis C
Cryoglobulinaemic Glomerulonephritis
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Informed consent form signed,
- Male or female at least 18 years of age at time of Screening.
- Chronic infection with Hepatitis C virus G1b
- Chronic infection with Hepatitis C virus G4 naïve, and experienced with baseline HCV RNA level \<800,000 IU/ml
- Metavir score ranging between F0-F4 (with Child-Pugh score ranging from A5 to A6)
- Diagnosis of mixed cryoglobulinemia MC (type III or II) according to standard criteria
- Chronic renal impairment due to cryoglobulinemic nephropathy. Subjects with renal impairment will include CKD Stage 5 (eGFR \< 15mL/min or dialysis dependent), CKD Stage 4 (eGFR 15-29 mL/min), CKD Stage 3 eGFR (30-59 mL/min) and CKD Stage 2 (60-89 mL/min) HCV patients.
- Albumin level ≥ 3.0 g/dl,
- Platelet count ≥ 75 x 103/μL.
Exclusion
- Age \<18 years
- Chronic infection with Hepatitis C virus G4 experienced with baseline HCV RNA level \>800,000 IU/ml
- Patients with HCV genotype 1a, 2, 3, 5, 6,
- Coexistence of life-threatening condition(s) unrelated to MC
- Diagnosis of malignancy
- Pregnancy or breast feeding.
- Child-Pugh score \> A6
- Decompensated cirrhosis or previous decompensation
- Platelet count \< 75 x 103/μL
- Albumin level \< 3 g/l
- Co-infection with more than one HCV genotype.
- Any serious or active medical illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance
- HIV or chronic hepatitis B virus (HBV) infection (HBsAg positive)
- Known hypersensitivity to Grazoprevir, Elbasvir or any of its components
Key Trial Info
Start Date :
March 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2018
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03433326
Start Date
March 1 2018
End Date
December 31 2018
Last Update
February 14 2018
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