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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01788371
Other study ID # 2011.6
Secondary ID
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


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
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