Grazoprevir and Elbasvir Without Ribavirin for 12 Weeks in Patients With HCV-related Cryoglobulinemic Nephropathy (CRYOKID)

University of Florence (UNIFI)

Status: Unknown

Conditions: Cryoglobulinaemic Glomerulonephritis; Hepatitis C

Treatments: Drug: Elbasvir/Grazoprevir

Study type: Observational

Funder types: Other

Identifiers

NCT03433326

56086

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Informed consent form signed,
2. Male or female at least 18 years of age at time of Screening.
3. Chronic infection with Hepatitis C virus G1b
4. Chronic infection with Hepatitis C virus G4 naïve, and experienced with baseline HCV RNA level <800,000 IU/ml
5. Metavir score ranging between F0-F4 (with Child-Pugh score ranging from A5 to A6)
6. Diagnosis of mixed cryoglobulinemia MC (type III or II) according to standard criteria
7. 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.
8. Albumin level ≥ 3.0 g/dl,
9. Platelet count ≥ 75 x 103/μL.

Exclusion criteria

1. Age <18 years
2. Chronic infection with Hepatitis C virus G4 experienced with baseline HCV RNA level >800,000 IU/ml
3. Patients with HCV genotype 1a, 2, 3, 5, 6,
4. Coexistence of life-threatening condition(s) unrelated to MC
5. Diagnosis of malignancy
6. Pregnancy or breast feeding.
7. Child-Pugh score > A6
8. Decompensated cirrhosis or previous decompensation
9. Platelet count < 75 x 103/μL
10. Albumin level < 3 g/l
11. Co-infection with more than one HCV genotype.
12. Any serious or active medical illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance
13. HIV or chronic hepatitis B virus (HBV) infection (HBsAg positive)
14. Known hypersensitivity to Grazoprevir, Elbasvir or any of its components