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

July 29, 2013 updated by: Hua Zhang, Beijing YouAn Hospital

The Efficacy and Safety of Telbivudine and Lamivudine Use in Highly Viremic Mothers to Prevent Hepatitis B Transmission

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study enrolls HBV mono-infected pregnant women cohorts managed in outpatient clinics/delivery unit at YouAn Hospital in Beijing. Subjects are prospectively followed from gestation week 26 to postpartum week 52. Treatment naïve mothers with HBV DNA > 6 log10 c/mL and normal ALT are eligible. Mothers with abnormal fetus, cirrhosis or evidence of hepatocellular carcinoma (HCC) are excluded. At gestation week 28, mothers will receive telbivudine (LdT) 600 mg per day or lamivudine (Lam) 100 mg per day until postpartum 4 or no treatment as per their preference. All infants will receive standard immunoprophylaxis. Data is collected from patient records using data extraction forms. Primary endpoints are vertical transmission rates at infants' age of 52 week and the safety of telbivudine or lamivudine use.

Study Type

Interventional

Enrollment (Actual)

700

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100069
        • Beijing YouAn Hospital

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:

  1. Age: 20-40 years old
  2. HBsAg, HBeAg positive and HBV DNA >6 log10 copies/ml
  3. Gestational age: 26-28 weeks with normal fetus
  4. Willing to consent for the study

Exclusion Criteria:

  1. Elevated ALT
  2. Antiviral treatment experience patients
  3. Co-infection with HAV, HCV,HDV, HIV
  4. Concurrent treatment with immune modulators, cytotoxic drugs, or steroids
  5. Clinical signs of threatened miscarriage in early pregnancy
  6. Clinical evidence of cirrhosis and/or hepatocellular carcinoma

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telbivudine
Mother receives telbivudine 600mg per day. Infant receives standard immunoprophylaxis
Drug: Telbivudine
LdT 600mg QD
Other Names:
  • LdT
Experimental: Lamivudine
Mother receives lamivudine 100mg per day. Infant receives standard immunoprophylaxis.
Drug: Lamivudine
LAM 100mg QD
Other Names:
  • LAM
No Intervention: No antiviral treatment
Mother receives no antiviral treatment. Infant receives standard immunoprophylaxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety on fetal exposure of telbivudine and lamivudine and vertical transmission rate from mother to child
Time Frame: From gestation week 26 to postpartum week 52
From gestation week 26 to postpartum week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
percentage of mothers with serum HBV DNA level reduction, ALT within normal range and HBeAg and/or HBsAg negativity with or without seroconversion
Time Frame: From gestation week 26 to pastpartume week 52
From gestation week 26 to pastpartume week 52

Collaborators and Investigators

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

Sponsor

Beijing YouAn Hospital

Collaborators

New Discovery LLC

Investigators

  • Principal Investigator: Hua Zhang, MD, Beijing YouAn Hospital
  • Study Director: Calvin Pan, MD, Division of Liver Diseases, Mount Sinai School of Medicine, Flushing, NY

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

January 1, 2009

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

December 3, 2012

First Submitted That Met QC Criteria

December 4, 2012

First Posted (Estimate)

December 6, 2012

Study Record Updates

Last Update Posted (Estimate)

July 30, 2013

Last Update Submitted That Met QC Criteria

July 29, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20080810

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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