Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Tolerant 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-tolerant, HBeAg-positive children aged 3-6 years with chronic hepatitis B virus infection.
Eligibility criteria
Qualifiers
Aged 3-6 (more than 3 but less than 7) years;
With chronic HBV infection;
HBeAg-positive;
HBV DNA >1.0×10⁷ 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
Treatments tested in this trial
- Entecavir
- Entecavir + Pegylated interferon α-2b
Treatment groups
80 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
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