Back to resultsEfficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission
Primary Purpose
Chronic Hepatitis B, Gestation
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Telbivudine
engineered HB vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B, Gestation focused on measuring Chronic hepatitis B, Telbivudine, Intrauterine transmission
Eligibility Criteria
Inclusion Criteria:
- 20-40 years old pregnant woman with gestational age of 20-32 week;
- positive serum HBsAg;
- HBV DNA≥1.0x106 copies/ml;
Exclusion Criteria:
- with previous antiviral treatment;
- with clinical sign of threatened miscarriage or related treatment in early pregnancy;
- positive serum HAV, HCV, HDV and HEV tests;
- fetus deformity by 3-D ultrasound examination;
- on other dugs, such as immune modulators, cytotoxic drugs or steroids;
- husbands are infected with HBV.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Telbivudine
Control
Arm Description
Drug administration and follow up: the subjects in Telbivudine group start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continue to one month after delivery.And their newborns are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20ug respectively at age of 0, 1 and 6 months.
The pregnant subjects in Control group are intervented with no drugs, but their newborns are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20ug respectively at age of 0, 1 and 6 months.
Outcomes
Primary Outcome Measures
the intrauterine transmission rate;vertical transmission rate (intrauterine and delivery)
Secondary Outcome Measures
liver function normalization rate; HBV DNA and HBeAg reduction and negative conversion rate;
drug adverse reaction in pregnant women; complications during pregnancy and delivery, gestational age at delivery, the method of delivery, peripartum hemorrhage, the newborn growth and development milestones, Apgar score, newborn deformity prevalence
Full Information
NCT ID
NCT00939068
First Posted
July 13, 2009
Last Updated
October 13, 2009
Sponsor
Southeast University, China
1. Study Identification
Unique Protocol Identification Number
NCT00939068
Brief Title
Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission
Official Title
A Study of Efficacy and Safety of Telbivudine in Pregnancy for the Prevention of Perinatal Transmission of Hepatitis B Virus Infection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
November 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Southeast University, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Telbivudine in pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.
Detailed Description
In the present study, we evaluated the effect of telbivudine given during the second and third trimesters of pregnancy to highly viremic, HBV DNA-positive mothers on maternal HBV DNA and HBeAg levels prior to delivery and the rate of vertical transmission of HBV to infants who received passive-active immunoprophylaxis. Additionally, we investigated the timing of the administration of telbivudine on reducing the risk of perinatal transmission and the safety of telbivudine during pregnancy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B, Gestation
Keywords
Chronic hepatitis B, Telbivudine, Intrauterine transmission
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Telbivudine
Arm Type
Experimental
Arm Description
Drug administration and follow up: the subjects in Telbivudine group start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continue to one month after delivery.And their newborns are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20ug respectively at age of 0, 1 and 6 months.
Arm Title
Control
Arm Type
Other
Arm Description
The pregnant subjects in Control group are intervented with no drugs, but their newborns are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20ug respectively at age of 0, 1 and 6 months.
Intervention Type
Drug
Intervention Name(s)
Telbivudine
Other Intervention Name(s)
telbivudine treatment
Intervention Description
Subjects start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continued to one month after delivery.
Intervention Type
Biological
Intervention Name(s)
engineered HB vaccine
Other Intervention Name(s)
control group
Intervention Description
All the newborns in control group are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20 ug respectively at age of 0, 1 and 6 months.
Primary Outcome Measure Information:
Title
the intrauterine transmission rate;vertical transmission rate (intrauterine and delivery)
Time Frame
1 month post partum
Secondary Outcome Measure Information:
Title
liver function normalization rate; HBV DNA and HBeAg reduction and negative conversion rate;
Time Frame
1 month post partum
Title
drug adverse reaction in pregnant women; complications during pregnancy and delivery, gestational age at delivery, the method of delivery, peripartum hemorrhage, the newborn growth and development milestones, Apgar score, newborn deformity prevalence
Time Frame
.1 year after childbirth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
20-40 years old pregnant woman with gestational age of 20-32 week;
positive serum HBsAg;
HBV DNA≥1.0x106 copies/ml;
Exclusion Criteria:
with previous antiviral treatment;
with clinical sign of threatened miscarriage or related treatment in early pregnancy;
positive serum HAV, HCV, HDV and HEV tests;
fetus deformity by 3-D ultrasound examination;
on other dugs, such as immune modulators, cytotoxic drugs or steroids;
husbands are infected with HBV.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Zhao, P.H.D
Organizational Affiliation
the Second Affiliated Hospital of Southeast University
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
28039902
Citation
Han GR, Jiang HX, Wang CM, Ding Y, Wang GJ, Yue X, Zhou L, Zhao W. Long-term safety and efficacy of telbivudine in infants born to mothers treated during the second or third trimesters of pregnancy. J Viral Hepat. 2017 Jun;24(6):514-521. doi: 10.1111/jvh.12670. Epub 2017 Feb 14.
Results Reference
derived
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Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission
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