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NCT01341808
Immunogenicity of Hepatitis A Vaccine in Patients With Inflammatory Bowel Disease
Phase 4 trial testing Epaxal Berna (virosomal hepatitis A vaccine) in Inflammatory Bowel Disease in 493 participants. Completed in 1 March 2013.
1 February 2013
Quick facts
| Lead sponsor | Asan Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 493 |
| Start date | 1 April 2011 |
| Primary completion | 1 February 2013 |
| Estimated completion | 1 March 2013 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Epaxal Berna (virosomal hepatitis A vaccine) — full drug profile →
Conditions studied
- Inflammatory Bowel Disease — all drugs for Inflammatory Bowel Disease →
- Crohn's Disease — all drugs for Crohn's Disease →
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
- Hepatitis A — all drugs for Hepatitis A →
Sponsor
Asan Medical Center
Who can join
Adults 18 to 40, any sex, with Inflammatory Bowel Disease or Crohn's Disease. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
antibody titer to hepatitis A vaccine
Time frame: Month 7
Sponsor's own description
The purpose of this study is to measure the immune response in 18-40 year old IBD patients after receiving the hepatitis A vaccine.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Immunomodulatory Nanosystems.
Feng X, Xu W, Li Z, Song W, et al · · 2019 · cited 252× · PMID 31508270 · DOI 10.1002/advs.201900101 -
Efficacy of hepatitis A vaccination and factors impacting on seroconversion in patients with inflammatory bowel disease.
Park SH, Yang SK, Park SK, Kim JW, et al · · 2014 · cited 57× · PMID 24284413 · DOI 10.1097/01.mib.0000437736.91712.a1
Verify or expand the search:
- PubMed search for NCT01341808
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Inflammatory Bowel Disease
Currently open trials in the same condition.
- NCT07210580 — Testing the Impact of Measurement-Based Care on Quality of Life and Disease Management Among Veterans With Inflammatory · NA · recruiting
- NCT07242248 — A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disea · recruiting
- NCT07102368 — A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany · recruiting
- NCT07252427 — Gut Microbiota in IBD With Comorbid Depressive Disorder · recruiting
- NCT06781827 — Research on the Use of Probiotics in the Prevention and Treatment of Inflammatory Bowel Disease · NA · recruiting
Other Asan Medical Center trials
Trials by the same sponsor.
- NCT07530393 — Blood Viscosity and Outcomes After Elective Craniotomy · not yet recruiting
- NCT07010497 — A Prospective Study to Evaluate the Safety and Efficacy of the Combination Therapy of Irpagratinib, Atezolizumab, and Be · Phase 2 · recruiting
- NCT07382505 — Prospective Cohort Study of Minimal Residual Disease(MRD) Testing for Early Recurrence Detection in Endometrial and Cerv · not yet recruiting
- NCT07489092 — Feasibility of a Digital Rehabilitation Platform in Patients After ICU Discharge · NA · recruiting
- NCT07431762 — Comparison of Anti-Thrombotic Treatments Between Aspirin and Warfarin During Initial Six Months After Bioprpsthetic Hear · Phase 4 · 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 NCT01341808 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Asan Medical Center
- Last refreshed: 16 March 2013
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/NCT01341808.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing