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

NCT ID: NCT03433326

Last Updated: 2018-02-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2018-12-31

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.

Conditions

Hepatitis C; Cryoglobulinaemic Glomerulonephritis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Elbasvir/Grazoprevir

Administration of MK-8742 (Elbasvir)/MK-5172 (Grazoprevir) for 12 weeks

Intervention Type: DRUG

Other Intervention Names

MK-8742/MK-5172

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florence

OTHER

Sponsor Role: lead

Responsible Party

Anna Linda Zignego

professor of internal medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ANNA LINDA ZIGNEGO, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florence

Central Contacts

ANNA LINDA ZIGNEGO, MD, PhD

Role: CONTACT

annalinda.zignego@unifi.it

+390552758 ext. 020

MONICA MONTI, PhD

Role: CONTACT

monica.monti@unifi.it

+390552758 ext. 088

Other Identifiers

56086

Identifier Type: -

Identifier Source: org_study_id