Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Active Chronic Hepatitis B
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-6
SponsorQing-Lei Zeng
About this trial
This study aims to evaluate the efficacy and safety of entecavir monotherapy versus sequential entecavir plus pegylated interferon α-2b in achieving functional cure in immune-active, HBeAg-positive children aged 3-6 years with chronic hepatitis B.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 3 and 6 (more than 3 but less than 7) years;
Chronic HBV infection;
Positive HBeAg;
HBV DNA >1.0×10⁴ IU/mL;
Disqualifiers
Previous antiviral treatment for chronic HBV infection;
Coinfection with hepatitis C, D, E, human immunodeficiency virus (HIV), Epstein-Barr virus, or cytomegalovirus;
Previous or current evidence of hepatocellular carcinoma or cirrhosis;
Coexistence of any other liver diseases such as autoimmune hepatitis, drug-induced liver injury or Wilson's disease;
Trial design
Design model
Parallel
Treatments tested in this trial
Entecavir
DrugReceive entecavir onotherapy throughout the 96-week treatment course, the dosage of entecavir is 0.015 mg/kg/day for those weighing between 10 and 30 kg; for those weighing more than 30 kg, the dosage is 0.5 mg/day, oral.
Entecavir + Pegylated interferon α-2b
DrugReceive entecavir (with dosing adjusted by body weight: 0.015 mg/kg/day for subjects weighing 10-30 kg, and 0.5 mg/day for those \>30 kg, oral) for the first 48 weeks, followed by combination therapy with pegylated interferon α-2b (104 μg/m², weekly, subcutaneous injection) for the remaining 48 weeks.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: EntecavirExperimental treatment 1 intervention
Group B: Entecavir plus Peg-IFN α-2bExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The rate of functional cure
Functional cure is defined as the loss of HBsAg to \<0.05 IU/mL and HBeAg clearance, with or without the presence of hepatitis B surface antibody (HBsAb) and hepatitis B e antibody (HBeAb), and undetectable HBV DNA (\<10 IU/mL) at the end of treatment, sustained through 24 weeks post-treatment.
Time frame
At 24 weeks after treatment cessation.Secondary outcomes
1
The rate of HBV DNA undetectable
Proportion of participants with HBV DNA undetectable, defined as HBV DNA \<10 IU/mL.
Time frame
At week 24, 48, 72, 96, 120 of the study.2
The rate of HBeAg loss
Proportion of participants with HBeAg loss, defined as HBeAg \<0.18 PEIU/mL.
Time frame
At week 24, 48, 72, 96, 120 of the study.3
The rate of HBsAg loss
Proportion of participants with HBsAg loss, defined as HBsAg \<0.05 IU/mL.
Time frame
At week 24, 48, 72, 96, 120 of the study.4
The rate of alanine aminotransferase elevation or flare
Proportion of participants with alanine aminotransferase elevation (\> 1 time the upper limit of normal, i.e., \>40 U/L) or flare rate, defined as ALT \>5 times the upper limit of normal (ULN), i.e., \>200 U/L.
Time frame
At any time during the study, i.e., from the date of patient enrollment through 24 weeks after treatment discontinuation.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Qing-Lei Zeng
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Sponsor institution
Henan Provincial People's Hospital
Collaborator
Luoyang Central Hospital
Collaborator
Xuchang Central Hospital
Collaborator
Luohe Central Hospital
Collaborator
Yongcheng People's Hospital
Collaborator
Sanmenxia Central Hospital
Collaborator
The Third Affiliated Hospital of Henan Medical University
Collaborator
Weishi County People's Hospital
Collaborator
The Sixth People's Hospital of Zhengzhou
Collaborator
The First Affiliated Hospital of Henan Medical University
Collaborator
Shangcheng County People's Hospital
Collaborator
The First Affiliated Hospital of Henan Polytechnic University
Collaborator
Nanyang Central Hospital
Collaborator
Source ClinicalTrials.gov
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