Clinical trial NCT03433326: Grazoprevir and Elbasvir Without Ribavirin for 12 Weeks in Patients With HCV-related Cryoglobulinemic Nephropathy
Official title: A Multicenter, Open Label, Pilot Study of MK-5172 (Grazoprevir)/MK-8742 (Elbasvir) Without Ribavirin for 12 Weeks in G1b and G4 Patients With HCV-related Cryoglobulinemic Nephropathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Cryoglobulinaemic Glomerulonephritis
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: G1b and G4 patients with HCV-related Cryoglobulinemic Nephropathy

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 Ribavirin in patients with HCV chronic hepatitis (G1b and G4) and cryoglobulinemic nephropathy.


Eligibility criteria: 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

Primary outcomes:
measure: SVR12
timeFrame: march 2018-october 2018
Secondary outcomes:
measure: SVR24
timeFrame: march 2018-december 2018
measure: Clinical response: improvement or disappearance of MC clinical and biochemical stigmata
timeFrame: march 2018-december 2018
measure: Tolerability: Number of participants experiencing an adverse event (AE)
timeFrame: march 2018-may 2018
Other outcomes:
Locations:
Study officials:
affiliation: University of Florence
name: ANNA LINDA ZIGNEGO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: