Trial | NCT01743079  Report issue

Title

Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B
The Efficacy and Safety of Telbivudine and Lamivudine Use in Highly Viremic Mothers to Prevent Hepatitis B Transmission

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    700
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.
This study enrolls HBV mono-infected pregnant women cohorts managed in outpatient clinics/delivery unit at YouAn Hospital in Beijing. Subjects are prospectively followed from gestation week 26 to postpartum week 52. Treatment naïve mothers with HBV DNA > 6 log10 c/mL and normal ALT are eligible. Mothers with abnormal fetus, cirrhosis or evidence of hepatocellular carcinoma (HCC) are excluded. At gestation week 28, mothers will receive telbivudine (LdT) 600 mg per day or lamivudine (Lam) 100 mg per day until postpartum 4 or no treatment as per their preference. All infants will receive standard immunoprophylaxis. Data is collected from patient records using data extraction forms. Primary endpoints are vertical transmission rates at infants' age of 52 week and the safety of telbivudine or lamivudine use.
Study Started
Jan 31
2009
Primary Completion
Jul 31
2013
Study Completion
Jul 31
2013
Last Update
Jul 30
2013
Estimate

Drug Telbivudine

LdT 600mg QD

  • Other names: LdT

Drug Lamivudine

LAM 100mg QD

  • Other names: LAM

Telbivudine Experimental

Mother receives telbivudine 600mg per day. Infant receives standard immunoprophylaxis

Lamivudine Experimental

Mother receives lamivudine 100mg per day. Infant receives standard immunoprophylaxis.

No antiviral treatment No Intervention

Mother receives no antiviral treatment. Infant receives standard immunoprophylaxis

Criteria 

Inclusion Criteria:

Age: 20-40 years old
HBsAg, HBeAg positive and HBV DNA >6 log10 copies/ml
Gestational age: 26-28 weeks with normal fetus
Willing to consent for the study

Exclusion Criteria:

Elevated ALT
Antiviral treatment experience patients
Co-infection with HAV, HCV,HDV, HIV
Concurrent treatment with immune modulators, cytotoxic drugs, or steroids
Clinical signs of threatened miscarriage in early pregnancy
Clinical evidence of cirrhosis and/or hepatocellular carcinoma
No Results Posted