Evaluation of the efficacy of combination therapy with entecavir and pegylated interferon in children with Hepatitis B Virus infection

Tajiri Hitoshi0 sites2 target enrollmentMarch 25, 2019

Overview

Combination therapy of entecavir and peginterferon was safe but not effective in the two cases.

Registry

who.int

Start Date

March 25, 2019

End Date

March 31, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Tajiri Hitoshi

•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.