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Optimal Time for Tenofovir Treatment of Anti-Hepatitis B Virus (HBV) During the Pregnancy

NCT02510963 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2016-08-10

No results posted yet for this study

Summary

To determine the optimal time for the Tenofovir treatment of anti-Hepatitis B Virus (HBV) during the pregnancy among women with chronic HBV infection and high HBV DNA load. This is a randomized, open-label, three-arms, parallel-controlled clinical trial. Pregnant women with high HBV load and normal liver function will be treated with tenofovir during the middle or late stage of pregnancy, started from 24th gestational week, 28th gestational week and 32th gestational week through 1 month postpartum, respectively. The HBV DNA load at 40th gestational week of mothers, the intrauterine HBV infection rate of infants will be compared across the three groups.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Tenofovir Disoproxil Fumarate

Use Tenofovir at 24week of gestation

DRUG

Tenofovir Disoproxil Fumarate

Use Tenofovir at 28week of gestation

DRUG

Tenofovir Disoproxil Fumarate

Use Tenofovir at 32week of gestation

Sponsors & Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Tianyan Chen, MD,PHD · First Affiliated Hospital Xi'an Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-06-30
Completion
2017-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02510963 on ClinicalTrials.gov