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

July 13, 2009
October 13, 2009
February 2008
July 2010   (final data collection date for primary outcome measure)
the intrauterine transmission rate;vertical transmission rate (intrauterine and delivery) [ Time Frame: 1 month post partum ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00939068 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission
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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis B, Gestation
  • 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
  • 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
  • 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.
    Intervention: Drug: Telbivudine
  • 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.
    Intervention: Biological: engineered HB vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
180
November 2010
July 2010   (final data collection date for primary outcome measure)

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.
Female
20 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00939068
H200804
Yes
Wei Zhao, the Second Hospital of Nanjing, China
Southeast University, China
Not Provided
Study Chair: Wei Zhao, P.H.D the Second Affiliated Hospital of Southeast University
Southeast University, China
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP