Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the efficacy and safety of telbivudine and lamivudine use during late pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing YouAn Hospital
• Collaborator: New Discovery LLC
• Treatments: Lamivudine; Telbivudine

Criteria

Inclusion Criteria:

1. Age: 20-40 years old

2. HBsAg, HBeAg positive and HBV DNA >6 log10 copies/ml

3. Gestational age: 26-28 weeks with normal fetus

4. Willing to consent for the study

Exclusion Criteria:

1. Elevated ALT

2. Antiviral treatment experience patients

3. Co-infection with HAV, HCV,HDV, HIV

4. Concurrent treatment with immune modulators, cytotoxic drugs, or steroids

5. Clinical signs of threatened miscarriage in early pregnancy

6. Clinical evidence of cirrhosis and/or hepatocellular carcinoma