Non-randomized clinical trial of the efficacy of entecavir and pegylated interferon in children with Hepatitis B Virus infection

JRCT ID: jRCTs051180151

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: chronic hepatitis B, HBV
• Date of first enrollment: 10/09/2015
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Eligible patients receive pegylated interferon 180 mcg/m2 body surface area weekly for 24 or 48 weeks. In addition, patients intake entecavir 0.01mg/kg/day for the first 12 weeks. Patients are followed for blood test two years after the end of therapy. The duration of pegylated interferon is decided on the responses in ALT levels and HBVDNA titers by attending physicians.

Outcome(s)

Primary Outcome

1. ALT normalization
2. Seroconversion in HBeAg and HBeAb system
3. Decrease in HBV DNA titers
lower than 4 log copies/ml
4. Decrease in HBsAg titers
lower than 1000 IU/ml

Secondary Outcome

(1)any side effects and their frequency,
(2)effect on growth rate

Key inclusion & exclusion criteria

• Age minimum: 3age
• Age maximum: 18age
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Tajiri Hitoshi