NCT07054359Toboroz
"HBV unIversal vs Point-Of-Care-based Antiviral treatMent to Prevent Mother-to-child Transmission"
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 8.
Rövid összefoglaló (regiszter, angolul)
To achieve global elimination of hepatitis B virus (HBV), it is crucial to eliminate HBV mother-to-child transmission (MTCT) by ensuring high coverage of birth dose vaccine and expanding the adoption of peripartum antiviral prophylaxis (PAP) by tenofovir. Current international guidelines require hepatitis B surface antigen (HBsAg)-positive pregnant women to undergo viral load (VL) quantification to identify those at high risk (VL ≥200,000 IU/mL) who should receive PAP. However, VL testing remains inaccessible in many low- and middle-income countries (LMICs), particularly in rural areas. Consequently, in the forthcoming guidelines, the WHO is going to issue a conditional recommendation for administering PAP to all HBsAg-positive women lacking access to VL testing. Although this universal strategy may appear promising for simplifying the diagnostic process, it may result in overtreating the majority of HBsAg-positive pregnant women, estimated at 85% in Africa and 70% in Asia, for whom birth dose vaccine is likely sufficient. Moreover, the real-world applicability of this strategy in LMICs has never been formally tested. As an innovative alternative, the adoption of a rapid point-of-care test for hepatitis B core-related antigen (HBcrAg-RDT) is proposed to identify women eligible for PAP.This test requires only a drop of capillary blood, eliminating the need for electricity or centrifugation, and can provide a reliable result within 45 minutes. Compared to the universal strategy, HBcrAg-RDT strategy is expected to be less expensive and could prevent unnecessary tenofovir exposure for both women and their fetuses. Our aim is to establish the non-inferiority of the HBcrAg-RDT strategy, in comparison to the universal strategy, in terms of effectiveness, defined as the reduction in maternal VL at the time of childbirth, a main driver of the MTCT risk. This will be approached through a multidisciplinary framework integrating health economics, implementation science, and health policy analysis.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 3200 (tervezett)
- Első benyújtás
- 2025. jan. 9.
- Kezdés
- 2026. aug. 10.
- Elsődleges befejezés
- 2028. nov. 10.
- Fő szponzor
- ANRS, Emerging Infectious Diseases
- Betegségek
- Hepatitis B (krónikus)
- NCT-szám
- NCT07054359
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 3200
- 2026. aug. 10. és az elsődleges befejezés (2028. nov. 10.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Any concomitant medical condition that, according to the clinical site investigator, would contraindicate participation in the study.
- Concurrent participation in any other study (unless approved in writing by the Global Principal Investigators).
Más betegség
- HIV co-infection.
- HBV treatment ongoing on the day of inclusion.
- Severe gravid disease at inclusion, which poses a life-threatening risk to the mother and/or child
Életkor
- Having at least one of the following criteria indicatives of the third trimester of pregnancy:
- Gestational Age-Based Exclusion:
- The reported gestational age is ≥28 weeks, based on the last menstrual period (LMP) if known.
- Ultrasound-Based Exclusion:
- Fetal biometry (e.g., head circumference, femur length) on ultrasound suggests a gestational age of ≥28 weeks.
- Fundal Height-Based Exclusion:
- Symphysis-fundal height (SFH) measurement of ≥ 28 cm which corresponds to approximately 28 weeks of gestation.
Kiket keres a vizsgálat
- ≥18 years old, or ≥ the legal age of majority as defined by each country, on the day of inclusion.
- Pregnancy.
- Intention to attend antenatal care visits in the Primary Health Center or the Rural Hospital
- Living in an area covered by the Primary Health Center or the Rural Hospital on the start date of the trial
- Positive HBsAg identified during the screening phase of the study
- Free, informed, and written consent, signed by the person and the investigator at the latest on the day of inclusion and before any examination carried out as part of the study.
Életkor a regiszterben: 18 év – 50 év · Nem: csak nők · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Tien lang District Health center | Haiphong | Vietnám | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.