Efficacy and safety of Ledipasvir/Sofosbuvir in chronic hepatitis C of Genotype1b with chronic kidney disease(eGFR30-60ml/min/1.73m2)
Not Applicable
- Conditions
- Chronic hepatitis C
- Registration Number
- JPRN-UMIN000027851
- Lead Sponsor
- ippon Medical School Chiba Hokusoh Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 700
Inclusion Criteria
Not provided
Exclusion Criteria
1.History of allergy to Ledipasvir and Sofosbuvir. 2.Decompensated liver cirrhosis 3.pregnant woman or lactating mother 4.Hepatocellular carcinoma, or other malignant tumor. 5.severe depression 6.Judged by investigator not to be appropriate for inclusion in this study 7.Patient with dialysis or patients with severe renal function disorder (eGFR<30ml/min/1.73m2) 8.Receiving contraindicated drugs for Ledipasvir and Sofosbuvir combined therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sustained virological response rate
- Secondary Outcome Measures
Name Time Method 1. Change in serum HCV RNA during treatment and follow-up duration 2. Change in hematological and biochemical test during treatment and follow-up duration 3.Change of renal function during a treatment period 4. Frequency of a side effect during a treatment period 5. Change in Mac-2 Binding Protein,hyaluronic acid, type IV collagen,gamma globulin during treatment and follow-up duration.