Clinical trial NCT06503796: Antiviral Therapy in Infants With HBV Infection
Official title: Antiviral Therapy in Infants With HBV Infection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: HBV
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 60
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the antiviral group and the control group
Primary purpose: TREATMENT

Brief summary: This study was a multicenter, prospective randomized controlled clinical study. A total of 60 HBV-infected infants with ALT ≤5 times the upper limit of normal (ULN) and without pathological jaundice were enrolled and randomized 1:1 into two groups: the control group and the antiviral treatment group. HBV-infected infants in the treatment group were treated with LAM before the age of 1 year and then combined with regular interferon for 52 weeks if they were still positive for HBV DNA and/or HBsAg after reaching the age of 1 year. The control group was followed up synchronously. Follow-up was conducted every 3 months during the study period. The main efficacy evaluation indexes: HBsAg conversion (functional cure) rate, HBeAg conversion rate, HBeAg seroconversion rate, HBV DNA conversion rate, HBsAg seroconversion rate, and ALT reversion rate at the end of 12 months of treatment and at 2 years of age.


Eligibility criteria: Inclusion Criteria:

* a. Age ≤ 1 year;
* b. HBsAg and HBV DNA positive;
* c. ALT ≤ 5 times the upper limit of normal (ULN) and no pathologic jaundice (two consecutive tests with an interval of 2 weeks - 3 months).
* d. Parents are willing to participate in the study and sign an informed consent form, for children without parents, all legal guardians of need to give informed consent.

Exclusion Criteria:

* a. Combined viral infections such as HAV, HCV, HDV, HEV, HIV, EBV, CMV, etc;
* b. Combination of other liver diseases, such as autoimmune hepatitis, drug-induced liver injury, Wilson's disease;
* c. WBC \<9 × 10\^9/L, or PLT \<90 × 10\^9/L;
* d. Combination of other systemic serious diseases or hereditary diseases, etc;
* e. Other conditions deemed by the investigator to be unsuitable for participation in this study.

Primary outcomes:
measure: The rate of HBsAg loss
timeFrame: 12months after intervention, 2 years old
Secondary outcomes:
measure: The rate of HBsAg seroconversion
timeFrame: 12months after intervention, 2 years old
measure: The rate of HBV DNA loss
timeFrame: 12months after intervention, 2 years old
measure: The rate of HBeAg loss
timeFrame: 12months after intervention, 2 years old
measure: The rate of HBeAg seroconversion
timeFrame: 12months after intervention, 2 years old
measure: ALT reversion rate
timeFrame: 12months after intervention, 2 years old
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 12months after intervention, 2 years old
Other outcomes:
Locations:
city: Beijing
country: China
facility: the Fifth Medical Center of PLA
Study officials:
affiliation: The fifth medical center of PLA
name: Junliang Fu
role: PRINCIPAL_INVESTIGATOR
References: