NCT03433326Unknown不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 主要终点
- SVR12
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
SVR12
时间窗: march 2018-october 2018
Percentage of participants achieving sustained virologic response 12 weeks after completing treatment (SVR12)
次要结局
- 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)
研究者
Anna Linda Zignego
professor of internal medicine
University of Florence
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