NCT05705427|CompletedPhase 4DMCFDA Drug
The COMBAT HBV Feasibility Trial
COMBAT-HBV
Simplifying Hepatitis B Care in Pregnancy by Combining Birth-dose Vaccine and Tenofovir: The COMBAT HBV Feasibility Trial
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Sponsor study identifier
interventional
317
1 country
1
Study Start
August 17, 2023
Actual (reported)Primary Completion
November 25, 2025
Actual (reported)Study Completion
November 25, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 25, 2025
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 20, 2023
Actual (reported)January 30, 2023
Actual (reported)August 17, 2023
Actual (reported)November 25, 2025
Actual (reported)November 25, 2025
Actual (reported)Safety (Pregnant Women): Number of Pregnant Women With Adverse Effects Related to Study Medications
Safety of TDF prophylaxis in pregnant women, defined as a composite of adverse events (# mild adverse events \[AEs\], # moderate-to-severe AEs), presence of side effects and alanine aminotransferase elevations ≥ 5x upper limit of normal
Up to study close-out visit, or up to 12 months
Safety (Infants): Number of Infants with Adverse Effects Related to Study Medications
Safety of maternal TDF for infants, defined as a composite of: Birth weight (grams), mid-upper arm circumference (centimeters), gestational age at delivery (weeks and days), delivery mode (vaginal vs C-section), APGAR scores (0-10), # of adverse events
At delivery
Feasibility (Recruitment): Number of Eligible Participants Who Were Enrolled in the Study
Recruitment is indicative of the number of pregnant women who are screened versus those actually enrolled in the study.
Up to study close-out visit, or up to 12 months
Sensitivity of the Hepatitis B Core-Related Antigen Test
Measured at Enrollment
Specificity of the Hepatitis B Core-Related Antigen Test
Measured at Enrollment
140 pregnant women in the experimental arm will receive tenofovir disoproxil fumarate (TDF) 300 milligrams (mg) daily, beginning at 28-32 weeks' gestation and continuing through 4 weeks' postpartum. Infants born to these women will be included in this arm and will receive a birth-dose of hepatitis B vaccine.
140 pregnant women in the placebo arm will receive a placebo pill daily, beginning at 28-32 weeks' gestation and continuing through 4 weeks' postpartum. Infants born to these women will be included in this arm and will receive a birth-dose of hepatitis B vaccine.
Pregnant women in the experimental arm will receive TDF daily beginning in the 3rd trimester of pregnancy and continuing through 1 month postpartum.
All infants born to women in the study will receive a birth-dose hepatitis B vaccine.
Université Protestant au Congo
Kinshasa, Democratic Republic of the Congo
Peyton Thompson, MD, MSCR
University of North Carolina, Chapel Hill
317 participants (actual enrollment reported by the registry).
Clinical Study to Evaluate the Efficacy and Safety of DA-2803 in Chronic Hepatitis B Patients
Feasibility (Refusal): Number of Eligible Participants Who Refused to Enroll in the Study
Refusal will be defined as the number of individuals who refuse enrollment upon initial recruitment.
Up to study close-out visit, or up to 12 months
Feasibility (Withdrawal): Number of Enrolled Participants Who Withdraw from the Study
Withdrawal is indicative of the number of enrolled participants who choose not to continue study activities after having been enrolled.
Up to study close-out visit, or up to 12 months
Feasibility (Retention): Number of Enrolled Participants Who Remain in the Study Through 6 Months Postpartum
Retention is defined as the number of participants who remain in the study through the 6-month postpartum visit.
Up to study close-out visit, or up to 12 months
Feasibility (Maintenance): Proportion of Study Visits Completed Per Participant
Adherence to study visits and procedures, defined as proportion of the actual number of visits attended divided by the expected study visits (8) and multiplied by 100.
Up to study close-out visit (12 months)
Acceptability (Lab Testing): Number of Mothers With Lab Testing Acceptability Scores >80%
Number of mothers who report the process of undergoing lab draws as "acceptable" in the exit survey. Range 0-100%, with 0% being unacceptable and 100% being acceptable.
Upon study close-out visit, or up to 12 months
Acceptability (Medication): Number of Mothers With Medication Acceptability Scores >80%
Number of mothers who report the process of taking the study medication as "acceptable" in the exit survey. Range 0-100%, with 0% being unacceptable and 100% being acceptable.
Upon study close-out visit, or up to 12 months
Preliminary Effectiveness: Number of Infants With HBV Positivity by Rapid Diagnostic Testing at 6 Months of Life to Indicate Mother-to-Child Transmission of HBV
Mother-to-child transmission of HBV is defined as HBsAg positivity in the infant at 6 months of life.
Measured at 6 months after birth
Pregnant women in the placebo arm will receive a placebo pill daily beginning in the 3rd trimester of pregnancy and continuing through 1 month postpartum.
Contact the study team to confirm eligibility.
First Submitted
January 20, 2023
First Posted
January 30, 2023
Study Start
August 17, 2023
Actual (reported)Primary Completion
November 25, 2025
Actual (reported)Study Completion
November 25, 2025
Actual (reported)Last Updated
February 19, 2026
Record last verified: 2026-02
Datasets will not be made publicly available because they contain protected health information. However, the authors will share de-identified participant data, alongside the study protocol, statistical analysis plan, and analytic code, upon reasonable request and with approval by an independent review committee (ie, learned intermediary). An executed Data Use/Sharing agreement with the University of North Carolina at Chapel Hill (UNC-CH) is required before data will be shared
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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