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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Hepatitis B Late Pregnancy Transmission Complication

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Telbivudine

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

Group Type EXPERIMENTAL

Telbivudine

Intervention Type DRUG

LdT 600mg QD

Lamivudine

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

Group Type EXPERIMENTAL

Lamivudine

Intervention Type DRUG

LAM 100mg QD

No antiviral treatment

Mother receives no antiviral treatment. Infant receives standard immunoprophylaxis

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telbivudine

LdT 600mg QD

Intervention Type DRUG

Lamivudine

LAM 100mg QD

Intervention Type DRUG

Other Intervention Names

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LdT LAM

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No