Safety and Efficacy of TAF to Prevent MTCT of HBV in Middle/Late Pregnancies With High HBV DNA Load
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-40
SponsorXingfei Pan
About this trial
Mother-to-child transmission (MTCT) is still the main transmission route of HBV in high-endemic areas, such as China, sub-Saharan Africa, etc. Some infants born of mothers with high HBV DNA load (≥2×10\^5 IU/ml) are still infected with HBV even if these infants receive the combined immunization on time. Therefore, guidelines including AASLD and EASL recommend that pregnant women with high HBV DNA load should take antiviral drugs (tenofovir disoproxil fumarate or telbivudine) to reduce MTCT of HBV from gestation 24-28 weeks.
However, side effects of TDF on infants are reported. For example, neutropenia and the decrease of bone mineral density are found in early age infants who are ever exposed to TDF during their fetal life.
Tenofovir alafenamide (TAF), a new prodrug of tenofovir (TFV), has a higher antiviral potency, a higher peripheral blood mononuclear cell (PBMC) intracellular tenofovir diphosphate (TFV pp) level and a lower plasma TFV concentration. As the successor of TDF, the dose of TAF that is took orally every day is approximately 1/10 of TDF. TAF has a much lower risk of kidney toxicity and has almost no effect on the bone mineral density. TAF has been approved and recommended as the first-line drug to treat patients with chronic hepatitis B (CHB) by AASLD, EASL, etc. However, there are relatively few data of TAF on pregnancies with high HBV DNA load. It is urgently to clarify the safety and efficacy of TAF on interrupting MTCT of HBV in pregnancies with high HBV DNA load.
In the present study, the investigators enroll middle/late pregnancies with high HBV DNA load(≥2×10\^5 IU/ml). The participants are randomly divided into two groups. Then the participants are treated with TAF or TDF respectively. All enrolled participants are followed-up for 2 years. Objectives of the present study are as follows:
A. To clarify safety and efficacy of TAF on interrupting MTCT of HBV in middle/late pregnancies with high HBV DNA load.
B. To clarify effects of TAF on obstetric complications in middle/late pregnancies with CHB.
C. To clarify effects of TAF on birth defects of infants born in mothers with CHB.
D. To clarify the change of virology and biochemistry indexes in women with CHB during pregnancy and postpartum.
E. To clarify effects of TAF treatment on participants. F. To clarify growth parameters of the infants exposed to TAF during their fetal life.
G. To clarify the pharmacokinetics of TAF in pregnant populations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age of 20-40 years.
Positive for HBsAg ≥6 months.
HBV DNA load of ≥ 2×10^5 IU/ml.
Gestation 24-28 weeks .
Disqualifiers
Patients with antibodies against HIV, HCV, HDV, or other forms of chronic liver disease.
Evidence of hepatocellular carcinoma, decompensated liver disease, auto-immune hepatitis, or significant renal, cardiovascular, respiratory or neurological comorbidity.
Concurrent treatment with nephrotoxic drugs, glucocorticoids, cytotoxic drugs, nonsteroidal anti-inflammatory drugs, or immune modulators.
Ultra-sonographic evidence of fetal deformity, abnormal fetal development or placental abnormality.
Trial population
We enroll Child-bearing age women with chronic HBV infection, who already become middle/late pregnancy, and visit in 3 hospitals (The Third Affiliated Hospital of Guangzhou Medical University, People's Hospital of Guangzhou Huadu District and He Xian Memorial Hospital of Guangzhou Panyu District).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: TAF group
Group B: TDF group
Trial outcomes
Primary outcomes
1
The proportion of interrupting MTCT
The proportion of HBV infection in the infants at 1 year of age. Testing for HBsAg in the infants between 7 and 12 months of age.
Time frame
During 7-12 months after birth2
HBV DNA load in pregnancies
HBV DNA load is measured during 24-28 weeks of gestation and at birth, respectively.
Time frame
After enrollment and up to delivery3
ALT levels in pregnancies
ALT levels are measured every month during pregnancy.
Time frame
After enrollment and up to delivery4
HBeAg conversion rate in pregnancies
HBeAg is measured every 6 months during pregnancy.
Time frame
After enrollment and up to deliverySecondary outcomes
1
Mode of delivery.
Recording the mode of delivery (vaginal delivery or cesarean delivery), and what kind of anesthesia (general anesthesia or combined spinal/epidural anesthesia) is used in the cesarean delivery.
Time frame
At the time of delivery2
The proportion of birth defects in the infants at 1 month age.
Measuring which kinds of congenital abnormality the infants have.
Time frame
Up to 1 month after birth3
Head circumferences of infants
Head circumferences of infants are measured and analyzed.
Time frame
Once a year up to 3 years old after birth4
Weights of infants
Weights of infants are measured and analyzed.
Time frame
Once a year up to 3 years after birthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xingfei Pan
Lead sponsor
The Third Affiliated Hospital of Guangzhou Medical University
Sponsor institution
Source ClinicalTrials.gov