Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B
NCT01743079 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 700
Last updated 2013-07-30
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.
Conditions
- Chronic Hepatitis B
- Late Pregnancy
- Transmission
- Complication
Interventions
- DRUG
-
Telbivudine
LdT 600mg QD
- DRUG
-
Lamivudine
LAM 100mg QD
Sponsors & Collaborators
-
New Discovery LLC
collaborator INDUSTRY -
Beijing YouAn Hospital
lead OTHER
Principal Investigators
-
Calvin Pan, MD · Division of Liver Diseases, Mount Sinai School of Medicine, Flushing, NY
-
Hua Zhang, MD · Beijing YouAn Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-01-31
- Primary Completion
- 2013-07-31
- Completion
- 2013-07-31
Countries
- China
Study Locations
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