|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 November 2012 |
|
Main ID: |
NCT01312012 |
|
Date of registration:
|
20/01/2011 |
|
Primary sponsor: |
|
|
Public title:
|
The Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus-drug Test
|
|
Scientific title:
|
The Effectiveness and Feasibility of Using Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus-drug Test |
|
Date of first enrolment:
|
January 2011 |
|
Target sample size:
|
120 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01312012 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Taiwan
| | | | | | | |
|
Contacts
|
|
Name:
|
Mei-Hwei Chang, PhD |
|
Address:
|
|
|
Telephone:
|
886+02-23123456 |
|
Email:
|
changmh@ntu.edu.tw |
|
Affiliation:
|
|
|
|
Name:
|
Mei-Hwei Chang, PhD |
|
Address:
|
|
|
Telephone:
|
886-02-23123456 |
|
Email:
|
changmh@ntu.edu.tw |
|
Affiliation:
|
|
|
|
Name:
|
Mei-Hwei Chang, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
National Taiwan University |
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- pregnant women in 30 to 32 weeks of gestation, with positive HBsAg and HBeAg,serum viral
load above 8log10 copies per mL
Exclusion Criteria:
- major systemic disease
- Pregnant woman with infection of human immunodeficiency virus or hepatitis C virus
- Pregnant woman is receiving any drug with antiviral activity or any form of drug
therapy for hepatitis B virus
- Pregnant woman whose ultrasonographic examination reveals congenital anomaly of the
fetus
- Pregnant woman whose amniocentesis reveals any genetic abnormality
Age minimum:
20 Years
Age maximum:
40 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Hepatitis B Virus Infection, Pregnancy
|
|
Intervention(s)
|
|
Drug: antiviral therapy
|
|
Primary Outcome(s)
|
|
child-HBsAg
[Time Frame: 6 months after delivery]
|
|
Secondary Outcome(s)
|
|
1. child HBsAg; 2.maternal viral load, HBeAg, and ALT
[Time Frame: 1. 12 months after delivery (infant); 2. 8 weeks after taking medication (mothers)]
|
|
Secondary ID(s)
|
|
201010078M
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|