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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01743079

Enrollment

700

Registered

2012-12-06

Start date

2009-01-31

Completion date

2013-07-31

Last updated

2013-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B, Complication, Late Pregnancy, Transmission

Keywords

Telbivudine, Lamivudine, safety, efficacy, pregnancy

Brief 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.

Detailed description

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.

Interventions

DRUGTelbivudine

LdT 600mg QD

DRUGLamivudine

LAM 100mg QD

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety on fetal exposure of telbivudine and lamivudine and vertical transmission rate from mother to child	From gestation week 26 to postpartum week 52

Secondary

Measure	Time frame
percentage of mothers with serum HBV DNA level reduction, ALT within normal range and HBeAg and/or HBsAg negativity with or without seroconversion	From gestation week 26 to pastpartume week 52

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026