A Study for G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir (NCT03144635) | Clinical Trial Compass
CompletedPhase 4
A Study for G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir
Japan80 participantsStarted 2017-04-01
Plain-language summary
The regimen using grazoprevir plus elbasvir treatment is promising in Japan, because it may safely be used for the elderly patients with renal dysfunction. Grazoprevir and elbasvir are metabolized in the liver and do not require dose-adjustment for patients with renal dysfunction. However, no data related to efficacy and safety of the grazoprevir plus elbasvir treatment for Japanese elderly patients with renal dysfunction (eGFR\<60 mL/min/1.73m2) have been reported. Therefore, physicians are at a loss whether or not to treat the patients with renal dysfunction due to no evidence.
The aim of this study is to investigate the improvement of serum endostatin level of Japanese patients with CKD stage 3 after grazoprevir (NS3/4A protease inhibitor) plus elbasvir (NS5A replication complex inhibitor) treatment by a prospective, multicenter cohort study.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Subjects aged 20 years or older.
✓. Patients positive for HCV RNA for over 6 months and infected with genotype 1b chronic hepatitis C, including compensated cirrhosis.
✓. Patients without co-infection of hepatitis B virus.
✓. Patients without co-infection of human immunodeficiency virus
✓. Patients with moderate chronic kidney disease (CKD stage 3) (eGFR: 30-59 mL/min/1.73m2). A diagnosis of CKD is only confirmed if repeated eGFR tests for at least 90 days.
Exclusion criteria
✕. Patients with decompensated cirrhosis (Child Pugh B and C)
✕. Patients with albumin \<3.0 g/dL and platelets \<75,000 /μL
✕. Patients with autoimmune hepatitis
✕. Constant heavy alcohol drinkers (converted to ethanol ≥60 g/day)
✕. Patients who have a history of hypersensitivity to grazoprevir and elbasvir
What they're measuring
1
Change of Serum Endostatin Level (ng/mL) From Baseline to 3 Months
Timeframe: 3 months
2
Change of eGFR Level (mL/Min/1.73m^2) From Baseline to 3 Months