Hepatitis B Infection Clinical Trial
Official title:
Tenofovir Disoproxil Fumarate in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus in Highly Viremic Mothers
Verified date | December 2019 |
Source | New Discovery LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | June 28, 2018 |
Est. primary completion date | April 28, 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 35 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Hepatobiliary Disease Hospital of Jilin Province | Chang Chun | Jilin |
China | Southwest Hospital | Chongqing | Chongqing |
China | The Second Affiliated Hospital of the Southeast University | Nanjing | Jiangsu |
China | Nanyang Central Hospital | Nanyang | Henan |
China | The Fifth Hospital of Shijiazhuang | Shijiazhuang | Hebei |
Lead Sponsor | Collaborator |
---|---|
New Discovery LLC | Gilead Sciences |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measure the number of infants who have HBV infection at the age of 28 weeks | From the date of birth to age of 28 weeks | ||
Primary | Assessment of the safety and tolerability of TDF, measure the number of participants and paired infants with adverse events | From the date of randomization until 28 weeks of postpartum. | ||
Secondary | Measure maternal HBV DNA reduction during the study period when compared to the baseline | From the date of radomization to the time of delivery (upto 12 weeks from the radomization) | ||
Secondary | Measure maternal HBV DNA reduction during the study period when compared to the baseline | From the date of radomization to the time of delivery (about 8 - 10 weeks from the radomization) | ||
Secondary | percentage of mothers with sero-negativity or sero-conversion of HBsAg and/or HBeAg in each group for comparison | From the date of randomization until 28 weeks of postpartum. |
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