NCT05705427CompletedPhase 4
The COMBAT HBV Feasibility Trial
Simplifying Hepatitis B Care in Pregnancy by Combining Birth-dose Vaccine and Tenofovir: The COMBAT HBV Feasibility Trial
Source: ClinicalTrials.gov · Last updated 19 Feb 2026
Brief summary (registry, in English)
This is a double-blind, randomized placebo-controlled trial (RCT) of a prophylaxis-for-all approach to prevention of mother-to-child transmission (PMTCT) of hepatitis B virus (HBV) in the Democratic Republic of Congo (DRC). HBV-infected pregnant women will be randomized to either receive tenofovir or placebo beginning at 28-32 weeks' gestation and continuing through 4 weeks' postpartum. Women will be followed every 4-6 weeks throughout the prenatal and postpartum period to evaluate for side effects related to the medication. Infants will receive a birth-dose of HBV vaccine, ideally within 24 hours. Participants will be followed longitudinally through 6 months' postpartum.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 317 (actual)
- First submitted
- 20 Jan 2023
- Start date
- 17 Aug 2023
- Primary completion date
- 25 Nov 2025
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Hepatitis B
- NCT number
- NCT05705427
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 317
- From 17 Aug 2023 to the primary completion date, 25 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any HIV-positive individual, determined by routine point-of-care screening at antenatal care visits
Lab values
- Individuals with abnormal creatinine by point-of-care testing
Other
- Any woman who plans to move outside of Kinshasa Province during the study period.
Who the study is looking for
- Pregnant women ≥18 years of age who present for routine prenatal care between 28-32 weeks' gestation and who test HBV-positive by point-of-care hepatitis B surface antigen test. Women must intend to seek maternity and postpartum care exclusively at one of the Kinshasa-based study maternity centers.
- Infants born to enrolled women will be included in the study
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Université Protestant au Congo Coordinator of this site? Confirm its status | Kinshasa | Democratic Republic of the Congo | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.