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

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

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 Overview

• Status: Unknown
• Conditions: Hepatitis C; Cryoglobulinaemic Glomerulonephritis
• Intervention / Treatment: Drug: Elbasvir/Grazoprevir

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

G1b and G4 patients with HCV-related Cryoglobulinemic Nephropathy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SVR12	Percentage of participants achieving sustained virologic response 12 weeks after completing treatment (SVR12)	march 2018-october 2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SVR24	Percentage of participants achieving Sustained Virologic Response 24 weeks after ending study treatment (SVR 24)	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.	march 2018-december 2018
Tolerability: Number of participants experiencing an adverse event (AE)	Tolerability: Number of participants experiencing an adverse event (AE)	march 2018-may 2018

Collaborators and Investigators

• Sponsor: University of Florence
• Investigators: Principal Investigator: ANNA LINDA ZIGNEGO, MD, PhD, University of Florence

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 14, 2018

Study Record Updates

• Last Update Posted (Actual): February 14, 2018
• Last Update Submitted That Met QC Criteria: February 8, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Kidney Diseases; Urologic Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Nephritis; Hepatitis; Hepatitis C; Glomerulonephritis; Anti-Infective Agents; Antiviral Agents; Grazoprevir; Elbasvir-grazoprevir drug combination
• Other Study ID Numbers: 56086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No