Status:
COMPLETED
Tenofovir in Pregnancy to Prevent Mother to Child Transmission of Hepatitis B.
Lead Sponsor:
University of Oxford
Conditions:
Hepatitis B
Tenofovir
Eligibility:
FEMALE
16-49 years
Phase:
PHASE2
Brief Summary
Hepatitis B virus (HBV) can be asymptomatic for years but can also lead to chronic hepatitis, hepatocellular carcinoma, and liver failure and death and cannot be eradicated with the current therapy. C...
Detailed Description
Participants with HBV mono infection and a measurable HBV DNA viral load attending SMRU antenatal clinics (ANC) on the Myanmar-Thailand border will be invited if they have a gestational age of at leas...
Eligibility Criteria
Inclusion
- Single viable pregnancy at enrollment day
- Estimated Gestational Age (EGA) 20-\<24 weeks for 2nd trimester or EGA 28-\<34 for 3rd trimester
- Willing and able to give informed consent for participation in the study
- Hepatitis B infected (HBsAg and HBeAg confirmed positive or HBsAg confirmed positive and HBV DNA detected in HBeAg negative)
- Burmese and Karen female, 16-49 years (inclusive)
- Willing to take TDF daily during pregnancy
- Plans to deliver at SMRU clinics
Exclusion
- Undetectable HBV DNA in HBeAg negative women
- HIV infected or other chronic illness incompatible with the study requirements or receiving Immunosuppressive therapy
- Creatinine at screening \>1 mg/dL
- Serum phosphate \<2.4 mg/dL
- History of chronic kidney disease
Key Trial Info
Start Date :
January 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2023
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04114890
Start Date
January 8 2021
End Date
September 29 2023
Last Update
March 27 2024
Active Locations (1)
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1
Shoklo Malaria Research unit (SMRU) clinics
Mae Sot, Changwat Tak, Thailand, 63110