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Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus

NCT01788371 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2013-07-30

No results posted yet for this study

Summary

To explore the antiviral effect of nucleoside analogue in late pregnancy and the safety of the antiviral drug to fetus.To establish the best therapy strategy to pregnant women with high level of HBV DNA.

Conditions

  • Hepatitis B Infection
  • Chronic Infection
  • Viremia

Interventions

DRUG

Telbivudine

About 300 mothers with no treatment observedfrom 28 weeks of pregnancy to the week 4 of postpartun

DRUG

Lamivudine

About 300 mothers treated with lamivudine or telbivudine from 28 weeks of pregancy to the week 4 of postpartum

Sponsors & Collaborators

Principal Investigators

  • Hua Zhang, MD · Beijing YouAn Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-07-31
Completion
2013-07-31

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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 NCT01788371 on ClinicalTrials.gov