Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Southeast University, China
ClinicalTrials.gov Identifier:
NCT00939068
First received: July 13, 2009
Last updated: October 13, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis B, Gestation
Drug: Telbivudine
Biological: engineered HB vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Efficacy and Safety of Telbivudine in Pregnancy for the Prevention of Perinatal Transmission of Hepatitis B Virus Infection

Resource links provided by NLM:


Further study details as provided by Southeast University, China:

Primary Outcome Measures:
  • the intrauterine transmission rate;vertical transmission rate (intrauterine and delivery) [ Time Frame: 1 month post partum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • liver function normalization rate; HBV DNA and HBeAg reduction and negative conversion rate; [ Time Frame: 1 month post partum ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: February 2008
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: telbivudine treatment
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 Name: control group

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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939068

Sponsors and Collaborators
Southeast University, China
Investigators
Study Chair: Wei Zhao, P.H.D the Second Affiliated Hospital of Southeast University
  More Information

No publications provided

Responsible Party: Wei Zhao, the Second Hospital of Nanjing, China
ClinicalTrials.gov Identifier: NCT00939068     History of Changes
Other Study ID Numbers: H200804
Study First Received: July 13, 2009
Last Updated: October 13, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Southeast University, China:
Chronic hepatitis B, Telbivudine, Intrauterine transmission

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Telbivudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014