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NCT01341808

Immunogenicity of Hepatitis A Vaccine in Patients With Inflammatory Bowel Disease

Completed Phase 4 Last updated 16 March 2013
What this trial tests

Phase 4 trial testing Epaxal Berna (virosomal hepatitis A vaccine) in Inflammatory Bowel Disease in 493 participants. Completed in 1 March 2013.

Timeline
1 April 2011
Primary endpoint
1 February 2013
1 March 2013

Quick facts

Lead sponsorAsan Medical Center
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment493
Start date1 April 2011
Primary completion1 February 2013
Estimated completion1 March 2013
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

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.

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):

  1. Immunomodulatory Nanosystems.
    Feng X, Xu W, Li Z, Song W, et al · · 2019 · cited 252× · PMID 31508270 · DOI 10.1002/advs.201900101
  2. 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:

Other recruiting trials for Inflammatory Bowel Disease

Currently open trials in the same condition.

Other Asan Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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