Effectiveness and safety of daclatasvir plus asunaprevir for chronic HCV genotype 1 infectio
Not Applicable
- Conditions
- Chronic HCV genotype 1b infection
- Registration Number
- JPRN-UMIN000015627
- Lead Sponsor
- Kyushu University Hospital
- Brief Summary
* Daclatasvir plus asunaprevir for HCV genotype 1b was well tolerated and effective for patients without pre-existent NS5A RAVs or simeprevir failure, irrespective of fibrosis status.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Not provided
Exclusion Criteria
1. Decompensated cirrhosis (Child B or C) 2. ALT level of more than five times the upper limit of normal range 3. Severe kidney damage (eGFR<30) 4. Coinfection with HBV or HIV 5. Women with pregnancy or breast feeding 6. Patients using contraindication drugs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sustained virological response (SVR)
- Secondary Outcome Measures
Name Time Method 1. Efficacy and safety for patients with older or CKD (HD) 2. Predictive factor of SVR 3. Evaluation of adverse effects 4. Relationship between treatment outcome and HCV resistance-associated substitutions to daclatasvir