Last reviewed · How we verify
NCT03343431
Antiviral Prophylaxis and Infant Vaccination to Prevent Perinatal Hepatitis B Infection
Phase 3 trial testing Anti-HBV antiviral prophylaxis in Hepatitis B in 504 participants. Participants enrolled and being followed up; not accepting new ones.
13 May 2023
Quick facts
| Lead sponsor | Institut de Recherche pour le Developpement |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 504 |
| Start date | 2 August 2018 |
| Primary completion | 13 May 2023 |
| Estimated completion | 30 June 2025 |
| Sites | 20 locations across Laos, Thailand |
Drugs / interventions tested
- Anti-HBV antiviral prophylaxis — full drug profile →
Conditions studied
- Hepatitis B — all drugs for Hepatitis B →
- Pregnancy — all drugs for Pregnancy →
Sponsor
Institut de Recherche pour le Developpement — full company profile →
Who can join
18 and older, female only, with Hepatitis B or Pregnancy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 pregnancy and for two months following delivery. Their infants will receive hepatitis B (HB) immunization, starting with a first dose soon after birth. We hypothesize that the risk of mother-to-child transmission of HBV will be lower than 2%. The results of the study will help define policy to manage HBV infected pregnant women to prevent perinatal transmission.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03343431
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hepatitis B
Currently open trials in the same condition.
- NCT04843852 — TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B · Phase 1 · recruiting
- NCT07168356 — A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease · Phase 1 · recruiting
- NCT06947356 — Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads · NA · recruiting
- NCT06537414 — A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living Wit · Phase 2 · active not recruiting
- NCT06623071 — Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384 · recruiting
Other Institut de Recherche pour le Developpement trials
Trials by the same sponsor.
- NCT07181278 — Optimization of Cervical Cancer Screening Strategies Among Women Living With HIV: Effectiveness and Implementation of De · NA · recruiting
- NCT05581212 — TB Case-Finding, Treatment and Prevention Intervention in Thailand · NA · not yet recruiting
- NCT06503393 — SENOVIE France - Therapeutic Mobility and Breast Cancer · completed
- NCT05466630 — Prospective Evaluation of the Specificity of Serological Tests for Human African Trypanosomiasis · NA · completed
- NCT05091489 — ANRS 12415 - Quali PrEP Cambodia · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03343431 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institut de Recherche pour le Developpement
- Last refreshed: 30 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03343431.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing