Tenofovir in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus
Information source: New Discovery LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B Infection; Chronic Infection; Viremia
Intervention: TDF treatment (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: New Discovery LLC Official(s) and/or principal investigator(s): Calvin Q Pan, MD, Study Chair, Affiliation: Leading Principle Investigator, Division of Gastroenterology and Hepatology, NYU Langone Medical Center, New York Zhongping Duan, MD, Study Director, Affiliation: Capital Medical University Shuqin Zhang, MD, Principal Investigator, Affiliation: Hepatobiliary Disease Hospital of Jilin Province, Jilin, China Erhei Dai, MD, Principal Investigator, Affiliation: The Fifth Hospital of Shijiazhuang, Shijiazhuang, Hebei, China Guorong Han, MD, Principal Investigator, Affiliation: The Second Affiliated Hospital of the Southeast University, Nanjing, China Huaihong Zhang, MD, Principal Investigator, Affiliation: Nanyang Central Hospital, Nanyang, Henan, China Yuming Wang, MD, Principal Investigator, Affiliation: Southwest Hospital, Chongqing, Chongqing, China
Summary
Immunoprophylaxis failure of hepatitis B virus (HBV) leading to vertical transmission
remains a concern and has been reported in approximately 8-15% of infants born to hepatitis
B e antigen (HBeAg) positive mothers with high levels of HBV DNA. Maternal HBV DNA > 6log10
copies/mL (or >200,000 IU/mL) is the major risk for the mother-to-child transmission. Prior
observational studies have shown that antiviral therapy including lamivudine or telbivudine
use during late pregnancy can safely reduce the rate of vertical transmission in this
special population compared to untreated patients.
Tenofovir Disoproxil (TDF), a pregnancy category B medication, reduces HBV DNA and
normalizes serum alanine aminotransferase (ALT) in chronic hepatitis B patients (CHB) with
few adverse effects. Two aspects on tenofovir use in pregnancy will be evaluated
prospectively in this study:
1. The data on its tolerability and safety in HBeAg+ pregnant women with HBV DNA > 6log10
copies/mL (or > 200,000 IU/mL) during late pregnancy and infants.
2. Its efficacy in the reduction of HBV vertical transmission rate.
Clinical Details
Official title: Tenofovir Disoproxil Fumarate in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus in Highly Viremic Mothers
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Measure the number of infants who have HBV infection at the age of 28 weeksAssessment of the safety and tolerability of TDF, measure the number of participants and paired infants with adverse events
Secondary outcome: Measure maternal HBV DNA reduction during the study period when compared to the baselinepercentage of mothers with sero-negativity or sero-conversion of HBsAg and/or HBeAg in each group for comparison
Detailed description:
Eligible mothers will be randomized (1: 1) to either TDF-treated group or untreated group
with about 100 subjects in each arm. The treatment group will receive TDF starting at week
30-32 of gestation until week 4 postpartum; follow up will continue until post-partum week
28 and infants age of 28 weeks. Untreated group will receive the standard of care with
similar follow-up schedule as the treatment group.
Eligibility
Minimum age: 20 Years.
Maximum age: 35 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- documented CHB infection with HBsAg positive > 6 months
- HBeAg+ CHB pregnant women
- gestational age between 30-32 weeks
- HBV DNA > 6 log10 copies/mL (or >200,000 IU/mL)
- both mother and father of the child are willing to consent for the study
Major Exclusion Criteria:
- co-infection with hepatitis A, C, D, E, HIV-1 or sexually transmitted disease (STD)
- decompensated liver disease or significant co-morbidity
- history of abortion, or diagnosis of fetal defect, or congenital malformation in
prior pregnancy
- antiviral used within six months prior to this pregnancy, or history of renal or
tubular function impairment due to adefovir.
- requirement for other medication during pregnancy to manage other chronic disease(s)
or concurrent treatment with immune-modulators, cytotoxic drugs, or steroids
- the biological father of the child had CHB
- clinical signs of threatened miscarriage in early pregnancy
- evidence of hepatocellular carcinoma
- maternal alanine aminotransferase (ALT) > or = 5 x upper limit of normal (U/mL), or
Total Bilirubin > or = 2, or glomerular filtration rate (GFR) < 100, or Albumin < 25
g/L
- evidence of fetal deformity by ultrasound examination
- patient is participating other clinical study
Locations and Contacts
Southwest Hospital, Chongqing, Chongqing 400038, China
The Fifth Hospital of Shijiazhuang, Shijiazhuang, Hebei 050021, China
Nanyang Central Hospital, Nanyang, Henan 473000, China
The Second Affiliated Hospital of the Southeast University, Nanjing, Jiangsu 210003, China
Hepatobiliary Disease Hospital of Jilin Province, Chang Chun, Jilin 130062, China
Additional Information
Starting date: December 2011
Last updated: June 7, 2015
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