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Study of Telbivudine and Lamivudine to Prevent Vertical Transmission of Hepatitis B

Sponsor
Beijing YouAn Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01743079
Collaborator
New Discovery LLC (Industry)
700
Enrollment
1
Location
3
Arms
53.9
Duration (Months)
13
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

This study enrolls HBV mono-infected pregnant women cohorts managed in outpatient clinics/delivery unit at YouAn Hospital in Beijing. Subjects are prospectively followed from gestation week 26 to postpartum week 52. Treatment naïve mothers with HBV DNA > 6 log10 c/mL and normal ALT are eligible. Mothers with abnormal fetus, cirrhosis or evidence of hepatocellular carcinoma (HCC) are excluded. At gestation week 28, mothers will receive telbivudine (LdT) 600 mg per day or lamivudine (Lam) 100 mg per day until postpartum 4 or no treatment as per their preference. All infants will receive standard immunoprophylaxis. Data is collected from patient records using data extraction forms. Primary endpoints are vertical transmission rates at infants' age of 52 week and the safety of telbivudine or lamivudine use.

Study Design

Study Type:
Interventional
Actual Enrollment :
700 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Efficacy and Safety of Telbivudine and Lamivudine Use in Highly Viremic Mothers to Prevent Hepatitis B Transmission
Study Start Date :
Jan 1, 2009
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Telbivudine

Mother receives telbivudine 600mg per day. Infant receives standard immunoprophylaxis

Drug: Telbivudine
LdT 600mg QD
Other Names:
  • LdT

    		•
    Experimental: Lamivudine

    Mother receives lamivudine 100mg per day. Infant receives standard immunoprophylaxis.

    Drug: Lamivudine
    LAM 100mg QD
    Other Names:
  • LAM

    		•
    No Intervention: No antiviral treatment

    Mother receives no antiviral treatment. Infant receives standard immunoprophylaxis

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age: 20-40 years old

    2. HBsAg, HBeAg positive and HBV DNA >6 log10 copies/ml

    3. Gestational age: 26-28 weeks with normal fetus

    4. Willing to consent for the study

    Exclusion Criteria:

    1. Elevated ALT

    2. Antiviral treatment experience patients

    3. Co-infection with HAV, HCV,HDV, HIV

    4. Concurrent treatment with immune modulators, cytotoxic drugs, or steroids

    5. Clinical signs of threatened miscarriage in early pregnancy

    6. Clinical evidence of cirrhosis and/or hepatocellular carcinoma

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing YouAn Hospital Beijing Beijing China 100069

    Sponsors and Collaborators

    • Beijing YouAn Hospital
    • New Discovery LLC

    Investigators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hua Zhang, Professor, Beijing YouAn Hospital
    ClinicalTrials.gov Identifier:
    NCT01743079
    Other Study ID Numbers:
    • 20080810
    First Posted:
    Dec 6, 2012
    Last Update Posted:
    Jul 30, 2013
    Last Verified:
    Jul 1, 2013
    Keywords provided by Hua Zhang, Professor, Beijing YouAn Hospital
    Telbivudine
    Lamivudine
    safety
    efficacy
    pregnancy
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis B
    Hepatitis B, Chronic
    Hepatitis
    Lamivudine
    Telbivudine

    Study Results

    No Results Posted as of Jul 30, 2013