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

NCT03433326 | Unknown FDA Drug

• 1 other identifier: 56086
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• SVR12

  Percentage of participants achieving sustained virologic response 12 weeks after completing treatment (SVR12)

  march 2018-october 2018

Secondary Outcomes (3)

• SVR24

  march 2018-december 2018

• Clinical response: improvement or disappearance of MC clinical and biochemical stigmata

  march 2018-december 2018

• Tolerability: Number of participants experiencing an adverse event (AE)

  march 2018-may 2018

Interventions

Elbasvir/Grazoprevir DRUG

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

Also known as: MK-8742/MK-5172

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

G1b and G4 patients with HCV-related Cryoglobulinemic Nephropathy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florence: lead

MeSH Terms

Conditions

Hepatitis C

Interventions

elbasvir-grazoprevir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• ANNA LINDA ZIGNEGO, MD, PhD

  University of Florence

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ANNA LINDA ZIGNEGO, MD, PhD

CONTACT

+390552758; annalinda.zignego@unifi.it

MONICA MONTI, PhD

CONTACT

+390552758; monica.monti@unifi.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of internal medicine

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 14, 2018
• Study Start: March 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 14, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share