Early Pregnancy, Hepatitis B Infection, Pregnant Women
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGTAF
Taking TAF from early or middle pregnancy
DRUGTDF
Taking TDF from early or middle pregnancy
Sponsors
The Third Affiliated Hospital of Guangzhou Medical University
Second Affiliated Hospital of Guangzhou Medical University
Qingyuan People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Between the ages of 20 and 40 * HBsAg positive for \>= 6 months * 0-24 week of pregnancy * Meets the indications for antiviral therapy in the 2022 version of the guidelines for the prevention and treatment of chronic hepatitis B * It is planned to use TAF or TDF antiviral therapy until the end of delivery or long-term administration, and follow-up will be carried out in this research institution * Signed informed consent for medication
Exclusion criteria
* Previous use of anti-hepatitis B virus drugs (e.g., entecavir, tenofovir, tenofovir alafenol, emintenofovir, adefovir dipoproxil, telbivudine, etc.) * Concomitant viral hepatitis A, C, E or other hepatotropic virus infection or AIDS * Concomitant cirrhosis, liver cancer or other chronic liver diseases (e.g., alcoholic liver, autoimmune liver disease, G6PD deficiency, etc.) * Patients with heart (such as coronary heart disease, myocardial infarction, heart failure, etc.), lung (such as: lung cancer, chronic obstructive pulmonary disease, tuberculosis, etc.), kidney (such as: renal failure, elevated creatinine, nephritis, nephrotic syndrome, etc.) and other important organ diseases * Chronic diseases such as autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, anticoagulant antibody syndrome), hypertension, diabetes, thyroid disease, etc * Patients with previous pregnancy complications (such as: gestational hypertension, gestational diabetes, gestational eclampsia, etc.) * Those who have had fetal or neonatal growth and development defects in previous pregnancies * Previous or ongoing use of nephrotoxic medications, glucocorticoids, nonsteroidal anti-inflammatory drugs, cytotoxic drugs, or immunomodulators * Premedication ultrasound showed fetal malformations, fetal development abnormalities, placental abnormalities, threatened abortion, etc
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the incidence of ALT above normal (>=1 time) of mother | not more than 48 weeks | From the time of initiation of antiviral and normal ALT until delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the level of HBV-DNA of baby | not more than 7 months | At birth; At 7 months of age |
| To assess the level of HBV-DNA of mother | not more than 48 weeks | Every 4 weeks of pregnancy |
| To assess the results of liver Ultrasound of mother | not more than 48 weeks | At the time of enrollment; During childbirth |
| To assess the weight in kilograms of baby | not more than 7 months | At birth; At 7 months of age |
| To assess the height in meters of baby | not more than 7 months | At birth; At 7 months of age |
| The number of HBsAg positive of baby | not more than 7 months | At birth; At 7 months of age |
| The number of HBeAg positive of baby | not more than 7 months | At birth; At 7 months of age |
| The number of HBsAg positive of mother | not more than 48 weeks | Every 4 weeks of pregnancy |
| The number of HBeAg positive of mother | not more than 48 weeks | Every 4 weeks of pregnancy |
| The rate of deformity | not more than 48 weeks | Fetal period |
| The rate of Birth defect | 1 day | At birth |
| The levels of creatinine of mother | not more than 48 weeks | From the time of initiation of antiviral until delivery |
| The levels of blood lipids of mother | not more than 48 weeks | From the time of initiation of antiviral until delivery |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORPanpan Zhai
The Third Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed