Status:
ACTIVE_NOT_RECRUITING
Antiviral Prophylaxis and Infant Vaccination to Prevent Perinatal Hepatitis B Infection
Lead Sponsor:
Institut de Recherche pour le Developpement
Collaborating Sponsors:
Chiang Mai University
Ministry of Health, Thailand
Conditions:
Hepatitis B
Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Most new hepatitis B virus (HBV) infections are acquired perinatally. In this study, pregnant women with HBsAg and HBeAg will receive tenofovir disoproxil fumarate during the last trimester of pregnan...
Detailed Description
This is a prospective multi-center, multi-country (Thailand and Lao PDR), open-label, single arm clinical trial in HBsAg and HBeAg positive pregnant women (from 28 weeks until one year postpartum) and...
Eligibility Criteria
Inclusion
- Pregnancy
- Age ≥18 years
- Negative HIV antibody test during current pregnancy
- Positive HBsAg test during current pregnancy
- Positive HBeAg using a rapid test during current pregnancy
- Absence of clinical symptoms of liver disease
- Gestational age of 28 weeks (+/- 7 days) based on the obstetrician judgment guided by the review of the date of last menstruation period.
- Willing and able to provide written informed consent
- Agreeing to bring her infants(s) at the planned study visits at one of the study site until the last visit (18 months after birth) and to inform the site investigators if plans to move to another place and not be able to return to the clinic
- Understand the need for adequate infant immunization for her infant(s) and accept that blood draws will be performed to determine the infant HBV infection status
Exclusion
- Receipt of anti-HBV antivirals at any time during the last 9 months
- Known liver cirrhosis or evidence of hepatocellular carcinoma
- Creatinine clearance \<50 ml/min, calculated using the Cockcroft-Gault formula
- Confirmed dipstick proteinuria \>1+ (\>30 mg/dL) or normoglycemic glycosuria
- 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 compromise adherence to treatment and satisfactory follow up in the study.
Key Trial Info
Start Date :
August 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT03343431
Start Date
August 2 2018
End Date
June 30 2025
Last Update
May 30 2025
Active Locations (20)
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1
Champasak Hospital
Champasak, Laos
2
Luang Prabang Provincial Hospital
Luang Prabang, Laos
3
Sayaboury Hospital
Sainyabuli, Laos
4
Savannakhet Provincial hospital
Savannakhet, Laos