Efficacy and Adverse Effects of Nucleoside Analogues (TDF/LDT) in Preventing Mother-to-child Transmission of HBV
Mother-to-Child-Transmission (MTCT) of HBV is the most important route in high endemic countries. Although active-passive immune prophylaxis is generally administrated to infants delivered by HBsAg positive women, there are a lot of people infected with HBV in China. High HBV DNA load (>10^5IU/ml) is the vital cause of MTCT. So some researchers used TDF （tenofovir） or LDT（telbivudine） to treat patients with high HBV DNA load during middle, late pregnancy, in order to decrease MTCT. As a result, some data about it were gradually reported in late years. Recently, American Association for the Study of Liver Diseases, European Association for the Study of Liver Diseases and China guidelines for CHB (chronic hepatitis B) suggest that pregnant women with high HBV DNA load be treated with TDF or LDT at 24-28 weeks of gestation to lower MTCT of HBV.
Although TDF or LDT is classified as pregnancy B drugs by FDA, and many studies report that MTCT rate of HBV decreases after women with high HBV DNA load are administrated with TDF or LDT at 24-28 weeks of gestation, a few birth defects are reported. Furthermore, the long-effect of TDF or LDT on infants remains unclear thoroughly.
Some CHB women had severe liver dysfunction before pregnancy or during pregnancy, and routine liver protection therapy could not effect. Some of them could develop into liver failure, fibrosis, cirrhosis, and even died. Moreover, severe liver dysfunction often leads to adverse effects to pregnant women and fetuses, such as pregnancy failure, lower weight, premature birth, etc. As a result, these women have to accept TDF or LDT before pregnancy, or during early pregnancy. So the long-effect of TDF or LDT on infants needs thoroughly investigating.
Taken together, the investigators will enroll women with chronic HBV infection and evaluate their state of illness. Then the investigators treat participants with TDF or LDT or routine liver protection therapy, and follow up the participants for a long period. The investigators' objectives are as follows:
A, To clarify efficacy and adverse effects of TDF/LDT in preventing MTCT between immune-tolerant and immune-active CHB patients.
B, To clarify efficacy and adverse effects of TDF/LDT in preventing MTCT during different trimesters of pregnancy.
C, To compare MTCT rate between patients received TDF/LDT therapy and patients without TDF/LDT therapy.
D, To compare MTCT rate and adverse effects between LDT and TDF.
|Chronic Hepatitis b Women|
|Study Design:||Observational Model: Case-Control
Time Perspective: Prospective
|Official Title:||The 3rd Affiliated Hospital, Guangzhou Medical University|
- The proportion of hepatitis B infections in the infants at 1 year of age [ Time Frame: Between 7-12 months after birth ]Testing for HBsAg in the infants between 7 and 12 months of age
- The proportion of birth defects in the infants at 1 month age [ Time Frame: From birth to 1 month age ]Measuring the number of infants with congenital abnormality
- Growth parameters of the infants [ Time Frame: From birth to 5 years age ]The infants'physical development status (head circumference, weight, and height) is measured and analyzed, respectively. Denver Developmental Screening Test is also analyzed.
- HBV DNA quantification of mothers [ Time Frame: From time of the inclusion to 5 years. ]HBV DNA quantification is detected at 24-28 weeks of gestation, at birth, every 6 month after postpartum.
- ALT levels of mothers [ Time Frame: From time of the inclusion to 5 years. ]ALT levels are measured every month during pregnancy and the first 3 months postpartum, and every 6 month from the fourth month of postpartum.
- HBeAg conversion rate of mothers [ Time Frame: From time of the inclusion to 5 years. ]HBeAg quantification is measured every 6 month.
|Actual Study Start Date:||June 9, 2017|
|Estimated Study Completion Date:||May 2022|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT03181607
|Contact: Xingfei Pan, Dr.||+86 20 firstname.lastname@example.org|
|Contact: Fang He, Dr.||+86 20 email@example.com|
|The 3rd Affiliated Hospital, Guangzhou Medical University||Recruiting|
|Guanzhou, Guangdong, China, 510150|
|Study Director:||Xingfei Pan, Dr.||The 3rd Affiliated Hospital, Guangzhou Medical University|