Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus

Sponsor

Hua Zhang (Other)

Overall Status

Completed

CT.gov ID

NCT01788371

Collaborator

Icahn School of Medicine at Mount Sinai (Other)

700

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B Infection Chronic Infection Viremia	Drug: Telbivudine Drug: Lamivudine	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

700 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Nucleoside Analogue in Late Preganancy to Prevent Vertical Transmission of Hepatitis B Virus

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: No antiviral arm provide standard of care to mothers and standard immunoprophylaxis to their infants
Experimental: Lamivudine lamivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants	Drug: Lamivudine About 300 mothers treated with lamivudine or telbivudine from 28 weeks of pregancy to the week 4 of postpartum
Experimental: Telbivudine Telbivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants	Drug: Telbivudine About 300 mothers with no treatment observedfrom 28 weeks of pregnancy to the week 4 of postpartun

Arm

Intervention/Treatment

No Intervention: No antiviral arm

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

Experimental: Lamivudine

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

Drug: Lamivudine

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

Experimental: Telbivudine

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

Drug: Telbivudine

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

Outcome Measures

Primary Outcome Measures

The data on its tolerability and safety in HBeAg+ pregnant woman with HBV DNA>6log10 copies/Ml during late pregnancy and infants [perinatal to 28 weeks after infant delivery]
Its efficacy in the reduction of HBV vertical transmission rate [perinatal to 28 weeks after infant delivery]

Secondary Outcome Measures

Maternal DNA reduction,ALT normalization, and loss/seroconversion of HBeAg or HBsAg [perinatal to 28 weeks of postpartum]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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