Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission

October 13, 2009 updated by: Southeast University, China

A Study of Efficacy and Safety of Telbivudine in Pregnancy for the Prevention of Perinatal Transmission of Hepatitis B Virus Infection

The purpose of this study is to evaluate the efficacy and safety of Telbivudine in pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In the present study, we evaluated the effect of telbivudine given during the second and third trimesters of pregnancy to highly viremic, HBV DNA-positive mothers on maternal HBV DNA and HBeAg levels prior to delivery and the rate of vertical transmission of HBV to infants who received passive-active immunoprophylaxis. Additionally, we investigated the timing of the administration of telbivudine on reducing the risk of perinatal transmission and the safety of telbivudine during pregnancy.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 20-40 years old pregnant woman with gestational age of 20-32 week;
  • positive serum HBsAg;
  • HBV DNA≥1.0x106 copies/ml;

Exclusion Criteria:

  • with previous antiviral treatment;
  • with clinical sign of threatened miscarriage or related treatment in early pregnancy;
  • positive serum HAV, HCV, HDV and HEV tests;
  • fetus deformity by 3-D ultrasound examination;
  • on other dugs, such as immune modulators, cytotoxic drugs or steroids;
  • husbands are infected with HBV.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telbivudine
Drug administration and follow up: the subjects in Telbivudine group start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continue to one month after delivery.And their newborns are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20ug respectively at age of 0, 1 and 6 months.
Drug: Telbivudine
Subjects start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continued to one month after delivery.
Other Names:
  • telbivudine treatment
Other: Control
The pregnant subjects in Control group are intervented with no drugs, but their newborns are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20ug respectively at age of 0, 1 and 6 months.
Biological: engineered HB vaccine
All the newborns in control group are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20 ug respectively at age of 0, 1 and 6 months.
Other Names:
  • control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the intrauterine transmission rate;vertical transmission rate (intrauterine and delivery)
Time Frame: 1 month post partum
1 month post partum

Secondary Outcome Measures

Outcome Measure
Time Frame
liver function normalization rate; HBV DNA and HBeAg reduction and negative conversion rate;
Time Frame: 1 month post partum
1 month post partum
drug adverse reaction in pregnant women; complications during pregnancy and delivery, gestational age at delivery, the method of delivery, peripartum hemorrhage, the newborn growth and development milestones, Apgar score, newborn deformity prevalence
Time Frame: .1 year after childbirth
.1 year after childbirth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Investigators

  • Study Chair: Wei Zhao, P.H.D, the Second Affiliated Hospital of Southeast University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

July 1, 2010

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

July 13, 2009

First Submitted That Met QC Criteria

July 13, 2009

First Posted (Estimate)

July 14, 2009

Study Record Updates

Last Update Posted (Estimate)

October 14, 2009

Last Update Submitted That Met QC Criteria

October 13, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H200804

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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