The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
NCT Number: NCT07668934
The goal of this clinical trial is to study the efficacy and safety of Tenofovir alafenamide (TAF) vs Tenofovir disoproxil fumarate(TDF) in early and middle pregnancy with chronic hepatitis B.
Interested in participating?
Request Info20 year–40 year
Female
Interventional
Phase 4
Guangzhou, Guangdong, China
The goal of this clinical trial is to study the efficacy and safety of Tenofovir alafenamide (TAF) vs Tenofovir disoproxil fumarate(TDF) in early and middle pregnancy with chronic hepatitis B. Previous studies have found that TAF has good clinical efficacy in the treatment of antiviral therapy in patients with chronic hepatitis B. In order to evaluate the clinical efficacy of TAF after antiviral therapy in pregnant women with chronic hepatitis B in the first and second trimesters, the clinical efficacy of TAF after antiviral therapy was evaluated by comparing the safety (including changes in maternal ALT, bilirubin, creatinine, blood phosphorus, blood lipids, fetal malformation rate, neonatal birth defects, head circumference, height, weight, intelligence and other indicators) and effectiveness (viral load decrease, serological conversion, mother-to-fetal blockade, etc.) with the TDF group.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Taking TAF from early or middle pregnancy
Other names: tenofovir alafenamide
Taking TDF from early or middle pregnancy
Other names: tenofovir disoproxil fumarate
Time frame: not more than 48 weeks
From the time of initiation of antiviral and normal ALT until delivery
Time frame: not more than 7 months
At birth; At 7 months of age
Time frame: not more than 48 weeks
Every 4 weeks of pregnancy
Time frame: not more than 48 weeks
At the time of enrollment; During childbirth
Time frame: not more than 7 months
At birth; At 7 months of age
Time frame: not more than 7 months
At birth; At 7 months of age
Time frame: not more than 7 months
At birth; At 7 months of age
Time frame: not more than 7 months
At birth; At 7 months of age
Time frame: not more than 48 weeks
Every 4 weeks of pregnancy
Time frame: not more than 48 weeks
Every 4 weeks of pregnancy
Time frame: not more than 48 weeks
Fetal period
Time frame: 1 day
At birth
Time frame: not more than 48 weeks
From the time of initiation of antiviral until delivery
Time frame: not more than 48 weeks
From the time of initiation of antiviral until delivery
The Third Affiliated Hospital of Guangzhou Medical University
Other
Efficacy and Safety of TAF Used in Early and Middle Pregnancy With Chronic Hepatitis B: a Multicenter Prospective Cohort Study
Acronym: TAF;CHB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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