Randomized trial of new oral anti hepatitis B drug (entecavir) plus interferon versus another oral anti hepatitis B drug (lamivudine) plus interferon in chronic hepatitis B in children.
- Conditions
- Health Condition 1: null- Children up to 18 years of age with chronic hepatitis B (HBsAg positive for more than 6 months)Health Condition 2: K768- Other specified diseases of liver
- Registration Number
- CTRI/2016/04/006820
- Lead Sponsor
- jjal Poddar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Children with either immune tolerant or immune reactive HBV will be included:Immune tolerant group: Children: 2-18 years of age of either sex with chronic HBV (HBsAg+ve for more than 24 weeks, HBeAg+ve, anti HBe-ve, DNA > 108IU/ml with normal or near normal ALT (within 2 times ULN) and liver histology shows normal or minimal changes.
Immune clearance or immune-reactive group: Children: 2-18 years of age of either sex with chronic HBV (HBsAg+ve for more than 24 weeks, HBeAg+ve, anti HBe-ve, DNA > 20,000 IU/ml but < 108 IU/ml with raised ALT ( > 2 times ULN) and liver histology shows necro-inflammatory activities.
Children less than 2 years of age, co-infection with HCV and HIV, advanced liver disease (decompensated cirrhosis), associated autoimmune diseases, neuropsychiatric illness, low platelet counts ( < 1, 00, 000), low total leucocyte count ( <3, 000), age <24 months, previous history of interferon or antiviral therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method