HBeAg positive Chronic Hepatitis B
Conditions
Interventions
Experimental:Drug (NAs + IFN for 96 weeks)
Control group:Drug (NAs for 48 weeks, then NAs combined with IFN for 96 weeks)
Sponsors
The fifth medical center of the General Hospital of the people's Liberation Army of China
Eligibility
Sex/Gender
All
Age
1 Years to 16 Years
Inclusion criteria
Inclusion criteria: 1. Aged 1 to 16 years old; 2. Chronic Hepatitis B (CHB) patients or HBsAg positive > 6 months patients are line with the diagnostic criteria for chronic hepatitis B infection; 3. ALT 40400 U/L; 4. HBeAg positive; 5. HBV DNA>2x10^4 IU/L; 6. Liver histology: G<3; 7. Agree to sign the Informed Consent Form (Children aged 1-6 years may be signed by the guardian; children between the ages of 7 and 11 are in principle signed by the child and the guardian; those over the age of 12 must be signed by the child and the guardian).
Exclusion criteria
Exclusion criteria: 1. WBC34umol/L; ALB133umol/L; 2. Combined with HAVHCVHDVHEV or HIV-infected persons; 3. Patients combined with other causes of liver diseasealcoholic or non-alcoholic liver diseasethyroid diseaseautoimmune liver diseasegenetic metabolic liver diseasebile duct diseasesor Parasitic infection of hepatobiliary tract; 4. Patients with decompensated cirrhosisincluding ascites; 5. Did not receive the following medications(Immunosuppressant and Systemic cytotoxic drugs)in six months; 6. Patients who are allergy to IFNs and NAs; 7. Patients with other serious or active psychosomatic diseases(kidney, heart, lungs, vascular, neurological, digestive including history of pancreatitis, metabolic diseases including diabetes, thyroid and Adrenal disease, adrenal disease or tumor),researchers believe which affect the treatment, evaluation or compliance of patients with the study plan; 8. Research judged patients who unable to comply with the study arrangement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rates of HBsAg serological disappearance / conversion in CHB patients at each visiting time point 48w?96w?stop point of IFN treatment and follow-up 24w.;1. Side effect and safety evaluation of antiviral therapy; 2. Average duration of HBeAg seroconversion during treatment; 3. Average duration of disappearance of HBsAg during treatment; 4. Changes of liver stiffness measure after antiviral therapy; 5. Rate of relapse in patients after stop of antiviral therapy of | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The rate of HBeAg clearance / seroconversion in patients with CHB; 2. HBVDNA negative conversion rate; 3. ALT recovery rate; | — |
Countries
China
Contacts
Public ContactZhang Min
The fifth medical center of the General Hospital of the people's Liberation Army of China
Outcome results
None listed