Status:
COMPLETED
Tenofovir in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus
Lead Sponsor:
New Discovery LLC
Collaborating Sponsors:
Gilead Sciences
Conditions:
Hepatitis B Infection
Chronic Infection
Eligibility:
FEMALE
20-35 years
Phase:
PHASE4
Brief 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) po...
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 u...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2018
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01488526
Start Date
March 1 2012
End Date
June 28 2018
Last Update
December 9 2019
Active Locations (5)
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1
Southwest Hospital
Chongqing, Chongqing Municipality, China, 400038
2
The Fifth Hospital of Shijiazhuang
Shijiazhuang, Hebei, China, 050021
3
Nanyang Central Hospital
Nanyang, Henan, China, 473000
4
The Second Affiliated Hospital of the Southeast University
Nanjing, Jiangsu, China, 210003