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

Hepatitis C Clinical Trial

— CRYOKID  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03433326
• Other study ID #: 56086
• Status: Not yet recruiting
• Phase: N/A
• First received: February 8, 2018
• Last updated: February 8, 2018
• Start date: March 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2018
• Source: University of Florence
• Contact: ANNA LINDA ZIGNEGO, MD, PhD
• Phone: +390552758
• Email: annalinda.zignego[@]unifi.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cryoglobulinaemic Glomerulonephritis
• Glomerulonephritis
• Hepatitis C

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SVR12	Percentage of participants achieving sustained virologic response 12 weeks after completing treatment (SVR12)	march 2018-october 2018
Secondary	SVR24	Percentage of participants achieving Sustained Virologic Response 24 weeks after ending study treatment (SVR 24)	march 2018-december 2018
Secondary	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
Secondary	Tolerability: Number of participants experiencing an adverse event (AE)	Tolerability: Number of participants experiencing an adverse event (AE)	march 2018-may 2018