A prospective multicenter study for characterization of renal function G1b CHC patients with CKD-3 treated with elbasvir plus grazoprevir
- Conditions
- Genotype 1b chrinic hepatitis C patients with CKD-3
- Registration Number
- JPRN-UMIN000026542
- Lead Sponsor
- Kyushu University
- Brief Summary
The overall sustained viral response (SVR) rates in the per protocol populations were 98.7% (76/77). High SVR12 rates were observed in almost all subgroups, including older age (over 75 years), cirrhosis, and history of HCC. There was no significant change during treatment or follow-up period in estimated glomerular filtration rate and endostatin level. In contrast, the serum complement level (C3 and C4) increased, with significance for C3. Serious adverse effects were very rare, and discontinuation was required for only two (2.5%) patients due to the ALT elevation during the second half of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
1.Decompensated liver cirrhosis (Child Pugh B/C) 2.Patients with co-infection with HBV or HIV 3.Patients who are pregnant females, or females who may become pregnant 4.Patients who are under medication with drugs listed as contraindication in a package insert 5.Patients judged to be inappropriate as subjects for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method