|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00523354 |
|
Date of registration:
|
30/08/2007 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Off Label Use of Infliximab in Adult Patients With Severe Eosinophilic Esophagitis
IEE |
|
Scientific title:
|
Phase 2 Proof-of-Concept Study to Analyze the Efficacy of in TNF-Alpha Blockade in Adult Patients With Severe, Corticosteroid-Dependent Eosinophilic Esophagitis |
|
Date of first enrolment:
|
August 2007 |
|
Target sample size:
|
|
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00523354 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Switzerland
| | | | | | | |
|
Contacts
|
|
Name:
|
Hans-Uwe Simon, MD and PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Deaprtment of Pharmacology, University Bern, Bern, Switzerland |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Adult patients with severe, corticosteroid-dependent eosinophilic esophagitis
Exclusion Criteria:
- Pregnancy
- Evidence of latent or active tuberculosis
- Other contra-indications for TNF-alpha blockers
- Unstable medical conditions
- Malignancies
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Esophagitis
|
|
Intervention(s)
|
|
Drug: Infliximab
|
|
Primary Outcome(s)
|
|
Tissue eosinophilia before and after therapy
|
|
Secondary ID(s)
|
|
Swiss EE-Study Group
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|