Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B

NCT01743079 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2013-07-30

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of telbivudine and lamivudine use during late pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.

Conditions

Interventions

DRUG

Telbivudine

LdT 600mg QD

DRUG

Lamivudine

LAM 100mg QD

Sponsors & Collaborators

  • New Discovery LLC

    collaborator INDUSTRY
  • Beijing YouAn Hospital

    lead OTHER

Principal Investigators

  • Calvin Pan, MD · Division of Liver Diseases, Mount Sinai School of Medicine, Flushing, NY

  • Hua Zhang, MD · Beijing YouAn Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • China

Study Locations

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Entities

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 NCT01743079 on ClinicalTrials.gov