on-randomized clinical trial of the efficacy of entecavir and pegylated interferon in children with Hepatitis B Virus infectio
- Conditions
- chronic hepatitis B, HBVB181
- Registration Number
- JPRN-jRCTs051180151
- Lead Sponsor
- Tajiri Hitoshi
- Brief Summary
Combination therapy of entecavir and peginterferon was safe but not effective in the two cases.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 2
1. Patient age is greater than 3 years of age and less than 18 years of age at the time of obtaining informed consent.
2. sustained elevation in ALT (greater than 60 IU/l) for more than six months.
3. Patients with HBeAg positive or negative.
4. HBVDNA titer greater than 4.0 log copies /ml
5. Fibrosis stage F2-3 or Hepatitis activity grade A2-3 according to the New Inuyama classification.
6. Written informed consent after adequate explanation and acceptance.
1. Patients with a suspicion of liver cirrhosis by blood examination or imaging studies.
2. Patients who is diagnosed as liver cirrhosis by pathological examination.
3. Patients with hepatocellular carcinoma.
4. Patients with poor adherence of medicine.
5. Patients who have any underlying disorders which can be affected by the treatment.
6. Patients who are assessed to be ineligible for this study by the principle investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. ALT normalization <br>2. Seroconversion in HBeAg and HBeAb system <br>3. Decrease in HBV DNA titers<br> lower than 4 log copies/ml <br>4. Decrease in HBsAg titers <br> lower than 1000 IU/ml
- Secondary Outcome Measures
Name Time Method (1)any side effects and their frequency,<br>(2)effect on growth rate