Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus

NCT ID: NCT01788371

Last Updated: 2013-07-30

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

2009-03-31

Study Completion Date

2013-07-31

Brief Summary

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To explore the antiviral effect of nucleoside analogue in late pregnancy and the safety of the antiviral drug to fetus.To establish the best therapy strategy to pregnant women with high level of HBV DNA.

Detailed Description

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Telbivudine and Lamivudine,a preganancy category B medication,reduces HBV DNA and normalizes serum ALT in chronic hepatitis B patients with few adverse effects.Two aspects on the drug use in pregnancy will be evaluated prospectively in this study.

Conditions

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Hepatitis B Infection Chronic Infection Viremia

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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No antiviral arm

provide standard of care to mothers and standard immunoprophylaxis to their infants

Group Type NO_INTERVENTION

No interventions assigned to this group

Lamivudine

lamivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants

Group Type EXPERIMENTAL

Lamivudine

Intervention Type DRUG

About 300 mothers treated with lamivudine or telbivudine from 28 weeks of pregancy to the week 4 of postpartum

Telbivudine

Telbivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants

Group Type EXPERIMENTAL

Telbivudine

Intervention Type DRUG

About 300 mothers with no treatment observedfrom 28 weeks of pregnancy to the week 4 of postpartun

Interventions

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Telbivudine

About 300 mothers with no treatment observedfrom 28 weeks of pregnancy to the week 4 of postpartun

Intervention Type DRUG

Lamivudine

About 300 mothers treated with lamivudine or telbivudine from 28 weeks of pregancy to the week 4 of postpartum

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

HBeAg+CHB pregnant woman gestational age 28 weeks HBV-DNA\>log10 copies/ml

Exclusion Criteria

co-infection with hepatitis A,C,D,E or HIV evidence of hepatocellular carcinoma decompensated liver disease or significant co-morbidity concurrent treatment with immune-modulators,cytotoxic drugs,or steroids clinical signs of threatened miscarriage in early prenancy evidence of fetal deformity by ultrasound examination the biological father of the child had CHB
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

Hua Zhang

OTHER

Sponsor Role lead

Responsible Party

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Hua Zhang

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hua Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing YouAn Hospital

Other Identifiers

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2011.6

Identifier Type: -

Identifier Source: org_study_id

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