Status:
NOT_YET_RECRUITING
Antiviral Therapy in Infants With HBV Infection
Lead Sponsor:
Beijing 302 Hospital
Conditions:
HBV
Eligibility:
All Genders
Up to 1 years
Phase:
PHASE4
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06503796
Start Date
August 1 2024
End Date
November 1 2026
Last Update
July 23 2024
Active Locations (1)
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1
the Fifth Medical Center of PLA
Beijing, China