- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01788371
Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus
Nucleoside Analogue in Late Preganancy to Prevent Vertical Transmission of Hepatitis B Virus
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No antiviral arm
provide standard of care to mothers and standard immunoprophylaxis to their infants
|
|
Experimental: Lamivudine
lamivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants
|
About 300 mothers treated with lamivudine or telbivudine from 28 weeks of pregancy to the week 4 of postpartum
|
Experimental: Telbivudine
Telbivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants
|
About 300 mothers with no treatment observedfrom 28 weeks of pregnancy to the week 4 of postpartun
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The data on its tolerability and safety in HBeAg+ pregnant woman with HBV DNA>6log10 copies/Ml during late pregnancy and infants
Time Frame: perinatal to 28 weeks after infant delivery
|
perinatal to 28 weeks after infant delivery
|
Its efficacy in the reduction of HBV vertical transmission rate
Time Frame: perinatal to 28 weeks after infant delivery
|
perinatal to 28 weeks after infant delivery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maternal DNA reduction,ALT normalization, and loss/seroconversion of HBeAg or HBsAg
Time Frame: perinatal to 28 weeks of postpartum
|
perinatal to 28 weeks of postpartum
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hua Zhang, MD, Beijing YouAn Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Systemic Inflammatory Response Syndrome
- Inflammation
- Disease Attributes
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Sepsis
- Enterovirus Infections
- Picornaviridae Infections
- Infections
- Communicable Diseases
- Hepatitis B
- Hepatitis
- Hepatitis A
- Viremia
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Lamivudine
- Telbivudine
Other Study ID Numbers
- 2011.6
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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