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NCT03405597
HBsAb Response After HBV Vaccination in Chronic Hepatitis B Patients Who Have Lost HBsAg
Phase 3 trial testing Commercial Hepatitis B vaccine in Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine in 97 participants. Status unknown.
28 February 2018
Quick facts
| Lead sponsor | Mahidol University |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 97 |
| Start date | 30 March 2017 |
| Primary completion | 28 February 2018 |
| Estimated completion | 30 June 2018 |
| Sites | 1 location across Thailand |
Drugs / interventions tested
- Commercial Hepatitis B vaccine — full drug profile →
- Standard Treatment
Conditions studied
- Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine — all drugs for Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine →
Sponsor
Mahidol University
Who can join
Adults 18 to 80, any sex, with Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Chronic HBV infection is major problem in Asian countries. Years after chronic infection, in some cases serum HBsAg level declines to unmeasurable level. Some of patients develop anti-HBsAb but there is no standard treatment to accelerate HBsAg seroconversion. There is a study to determine efficacy and safety of HBV vaccine in who is Chronic HBV infection and lost their HBsAg without seroconversion to anti-HBsAb.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03405597
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Commercial Hepatitis B vaccine
Trials testing the same drug.
- NCT03038802 — A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection · Phase 1, PHASE2 · not yet recruiting
Other Mahidol University trials
Trials by the same sponsor.
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- NCT07378501 — Thai Version of the Pediatric Quality of Recovery Score (PedSQoR): Translation and Psychometric Validation Study · not yet recruiting
- NCT07438301 — Septic Shock Hemodynamic Respond to Volume Resuscitation Versus Vasopressor Administration · not yet recruiting
- NCT07390006 — Enabling Patient-Reported Outcomes Through Innovative Care - ACS (EPIC-ACS) · NA · not yet recruiting
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 NCT03405597 (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 Mahidol University
- Last refreshed: 23 January 2018
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/NCT03405597.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing