Phase
Condition
Hepatitis
Liver Disorders
Hepatitis B
Treatment
Lamivudine Oral Solution
Tenofovir Disoproxil Fumarate
Clinical Study ID
Ages 16-50 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
prenatal clinic patient,
age ≥16 years,
14-32 weeks gestational age according to clinic dating based on LMP or ultrasound,
active hepatitis B with risk of vertical transmission (HBsAg+ AND HBeAg+ or HBV DNA >1000 IU/ML),
plan to receive follow up care and deliver at study facility,
capable of providing informed consent.
Exclusion
Exclusion Criteria:
HIV positive (according to HIV antibody testing performed at the initial prenatalvisit)
known liver cirrhosis or end-stage liver disease,
elevated liver enzymes (ALT >5x upper limit of normal),
elevated serum creatinine (>1.4 mg/dl)
currently taking tenofovir medication
allergy or intolerance to tenofovir study medication,
known fetal anomaly in the current pregnancy,
clinical illness requiring hospitalization at the time of enrollment
evidence of early labor at the time of enrollment.
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesActive - Recruiting
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