Trials / Unknown
UnknownNCT00939068
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
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- Sponsor
- Southeast University, China · Academic / Other
- Sex
- Female
- Age
- 20 Years – 40 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2008-02-01
- Primary completion
- 2010-07-01
- Completion
- 2010-11-01
- First posted
- 2009-07-14
- Last updated
- 2009-10-14
Source: ClinicalTrials.gov record NCT00939068. Inclusion in this directory is not an endorsement.