Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission

Chronic Hepatitis B, Gestation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00939068
• Other study ID #: H200804
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: July 13, 2009
• Last updated: October 13, 2009
• Start date: February 2008
• Est. completion date: November 2010

Study information

• Verified date: October 2009
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 180
• Est. completion date: November 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B, Gestation
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Telbivudine
Subjects start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continued to one month after delivery.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the intrauterine transmission rate;vertical transmission rate (intrauterine and delivery)		1 month post partum	No
Secondary	liver function normalization rate; HBV DNA and HBeAg reduction and negative conversion rate;		1 month post partum	No
Secondary	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		.1 year after childbirth	Yes