Maternal Antiviral Prophylaxis to Prevent Perinatal Transmission of Hepatitis B Virus in Thailand

• Status: Completed
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

Chronic hepatitis B (CHB) infection is complicated by cirrhosis and liver cancer. In Thailand, 7% of adults are chronically infected by Hepatitis B virus (HBV). The risk of perinatal transmission of HBV is about 12% when a mother has a high HBV load in her plasma, even if her infant receive specific immunoglobulin and vaccine.

The hypothesis of this study is that a potent antiviral, tenofovir, can decrease HBV load in HBV infected pregnant women and therefore reduce the risk of perinatal transmission/ Pregnant women participating in this study will receive tenofovir or placebo during the last trimester of pregnancy and two months postpartum. The risk of perinatal transmission will be compared between the two groups.

The results of the study will help define policy to manage HBV infected pregnant women to prevent perinatal transmission.

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

Details

• Lead Sponsor: Institut de Recherche pour le Developpement
• Collaborators: Centers for Disease Control and Prevention; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Gilead Sciences
• Treatments: Tenofovir

Criteria

Inclusion Criteria:

• Pregnancy

• At least 18 years of age

• Negative Human Immunodeficiency Virus (HIV) serology

• Positive HBsAg and hepatitis B e antigen (HBeAg) tests

• Gestational age of 28 weeks (+ or - 10 days) as determined by obstetrician

• Alanine Aminotransferase (ALT)≤30 U/L, confirmed ≤60 U/L on a subsequent blood draw

• Agreeing to bring their infants at the planned study visits at one study site until one year after delivery and to inform the site investigators if they plan to move to another place and not be able to return to the clinic.

• Understanding the need for adequate infant immunization and agreeing to the blood draws from their infants and the need for close follow up to manage possible exacerbation of hepatitis.

Exclusion Criteria:

• History of tenofovir treatment at any time, or any other anti-HBV treatment during the current pregnancy

• Creatinine clearance <50 ml/min, calculated using the Cockcroft-Gault formula

• Dipstick proteinuria>1+ (>30 mg/dL) or normoglycemic glucosuria confirmed on two separate occasions

• Positive serology for Hepatitis C infection less than 12 months prior to enrollment

• Evidence of pre-existing fetal anomalies incompatible with life

• Any concomitant condition or treatment that, in the view of the clinical site investigator, would contraindicate participation or satisfactory follow up in the study.

• Concurrent participation in any other clinical trial without written agreement of the two study teams