Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B
The Efficacy and Safety of Telbivudine and Lamivudine Use in Highly Viremic Mothers to Prevent Hepatitis B Transmission
1 other identifier
interventional
700
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of telbivudine and lamivudine use during late pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2009
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 3, 2012
CompletedFirst Posted
Study publicly available on registry
December 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJuly 30, 2013
July 1, 2013
4.5 years
December 3, 2012
July 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety on fetal exposure of telbivudine and lamivudine and vertical transmission rate from mother to child
From gestation week 26 to postpartum week 52
Secondary Outcomes (1)
percentage of mothers with serum HBV DNA level reduction, ALT within normal range and HBeAg and/or HBsAg negativity with or without seroconversion
From gestation week 26 to pastpartume week 52
Study Arms (3)
Telbivudine
EXPERIMENTALMother receives telbivudine 600mg per day. Infant receives standard immunoprophylaxis
Lamivudine
EXPERIMENTALMother receives lamivudine 100mg per day. Infant receives standard immunoprophylaxis.
No antiviral treatment
NO INTERVENTIONMother receives no antiviral treatment. Infant receives standard immunoprophylaxis
Interventions
Eligibility Criteria
You may qualify if:
- Age: 20-40 years old
- HBsAg, HBeAg positive and HBV DNA \>6 log10 copies/ml
- Gestational age: 26-28 weeks with normal fetus
- Willing to consent for the study
You may not qualify if:
- Elevated ALT
- Antiviral treatment experience patients
- Co-infection with HAV, HCV,HDV, HIV
- Concurrent treatment with immune modulators, cytotoxic drugs, or steroids
- Clinical signs of threatened miscarriage in early pregnancy
- Clinical evidence of cirrhosis and/or hepatocellular carcinoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing YouAn Hospitallead
- New Discovery LLCcollaborator
Study Sites (1)
Beijing YouAn Hospital
Beijing, Beijing Municipality, 100069, China
Related Publications (1)
Zhang H, Pan CQ, Pang Q, Tian R, Yan M, Liu X. Telbivudine or lamivudine use in late pregnancy safely reduces perinatal transmission of hepatitis B virus in real-life practice. Hepatology. 2014 Aug;60(2):468-76. doi: 10.1002/hep.27034. Epub 2014 Jan 27.
PMID: 25187919DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Calvin Pan, MD
Division of Liver Diseases, Mount Sinai School of Medicine, Flushing, NY
- PRINCIPAL INVESTIGATOR
Hua Zhang, MD
Beijing YouAn Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 3, 2012
First Posted
December 6, 2012
Study Start
January 1, 2009
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
July 30, 2013
Record last verified: 2013-07