Reducing Vertical Transmission of Hepatitis B in Africa

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

Hepatitis B virus is an infection that can be easily transmitted from women to newborns at the time of delivery. Our objective is to identify novel options that are effective and safe in preventing perinatal transmission of hepatitis B in Africa. The REVERT-B study (Reducing Vertical Transmission of Hepatitis B in Africa) is a clinical trial designed to test a new strategy of using antiviral medication in high-risk pregnant women and newborns to reduce the risk of hepatitis B transmission. The study will measure efficacy, safety, tolerability and adherence to medication.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); NIH-NICHD
• Treatments: Lamivudine; Tenofovir

Criteria

Inclusion Criteria:

• prenatal clinic patient,

• age ≥16 years,

• 14-27 weeks gestational age according to clinic dating based on LMP or ultrasound,

• active hepatitis B with high risk of vertical transmission (HBsAg+, HBeAg+),

• plan to receive follow up care and deliver at study facility,

• capable of providing informed consent.

Exclusion Criteria:

• HIV positive (according to HIV antibody testing performed at the initial prenatal visit)

• known liver cirrhosis or end-stage liver disease,

• elevated liver enzymes (ALT >3x 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.