Safety and Efficacy of TAF to Prevent MTCT of HBV in Middle/Late Pregnancies With High HBV DNA Load
NCT ID: NCT05466071
Last Updated: 2023-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2021-07-01
2024-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TAF group
Patients who take TAF during pregnancy.
No interventions assigned to this group
TDF group
Patients who take TDF during pregnancy.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Positive for HBsAg ≥6 months.
* HBV DNA load of ≥ 2×10\^5 IU/ml.
* Gestation 24-28 weeks .
* Pregnancies are orally administrated with TAF (25mg/day) or TDF (300mg/day) from 24-28 weeks of gestation.
* The good compliance of patients.
Exclusion Criteria
* 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.
* Clinical signs of threatened miscarriage.
* History of complication of pregnancy.
* History of nucleoside analogues (NA) treatment.
20 Years
40 Years
FEMALE
No
Sponsors
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Xingfei Pan
OTHER
Responsible Party
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Xingfei Pan
Director of Department of Infectious Diseases
Locations
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The Third Affiliated Hospital, Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Xingfei Pan, Doctor
Role: primary
Other Identifiers
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LCYJ-2021-005
Identifier Type: -
Identifier Source: org_study_id