Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503796
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Antiviral Therapy in Infants With HBV Infection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Antiviral Therapy in Infants With HBV Infection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None