PegIFNalpha-2a treatment added-on entecavir for HBeAg and HBV DNA negative patients treated with long-term entecavir
Not Applicable
Recruiting
- Conditions
- chronic hepatitis B
- Registration Number
- JPRN-UMIN000012454
- Lead Sponsor
- Toranomon Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients receiving Chinese herb (sho-sai-ko-to) 2) Patients with history of interstitial pneumonia 3) Patients with auto immune hepatitis 4) Patients with hypersensitivity to interferon 5) Patients with hypersensitivity to biological agents 6) Patients with neutropenia (<1500/mm3), thrombocytopenia (<90000/mm3), or anemia (Hb<12g/dL) 7) Cirrhotic patients 8) Patients with history of HCC 9) Doctors consider inadequate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The reduction of HBsAg and the number of patients who achieve >0.5 log U/mL at 48 weeks after randomization
- Secondary Outcome Measures
Name Time Method 1) The change of HBsAg levels at 1Y, 2Y and 3Y after peg interferon add-on treatment 2) Clearance rates of HBsAg and rates of < 100 U/mL or <1000 U/m