Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus

Hepatitis B Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01788371
• Other study ID #: 2011.6
• Status: Completed
• Phase: Phase 4
• First received: February 7, 2013
• Last updated: July 29, 2013
• Start date: March 2009
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Beijing YouAn Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: July 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Infection
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Infection
• Infection
• Viremia

Intervention

Drug:
• Telbivudine
About 300 mothers with no treatment observedfrom 28 weeks of pregnancy to the week 4 of postpartun
• Lamivudine
About 300 mothers treated with lamivudine or telbivudine from 28 weeks of pregancy to the week 4 of postpartum

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hua Zhang	Icahn School of Medicine at Mount Sinai

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Its efficacy in the reduction of HBV vertical transmission rate		perinatal to 28 weeks after infant delivery	Yes
Secondary	Maternal DNA reduction,ALT normalization, and loss/seroconversion of HBeAg or HBsAg		perinatal to 28 weeks of postpartum	Yes