Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission

Southeast University, China

Status and phase: Unknown; Phase 4

Conditions: Chronic Hepatitis B, Gestation

Treatments: Drug: Telbivudine; Biological: engineered HB vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT00939068

H200804

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Telbivudine

Experimental group

Description:

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.

Treatment:

Drug: Telbivudine

Control

Other group

Description:

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.

Treatment:

Biological: engineered HB vaccine