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Sponsored by: |
Neovacs |
---|---|
Information provided by: | Neovacs |
ClinicalTrials.gov Identifier: | NCT00808262 |
Evaluation of the safety and the immune response induced by active immunization through a TNFa kinoid in patients with Crohn's disease.
Condition | Intervention | Phase |
---|---|---|
Crohn's Disease |
Biological: TNFa Kinoid |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II, Open-Label, Escalating Dose, "Optimal Two-Stage", Study of TNFα-Kinoid (TNF- K) Immunization in Crohn's Disease Patients |
Estimated Enrollment: | 18 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
TNFa Kinoid dose 1: Experimental |
Biological: TNFa Kinoid
TNFa kinoid at days 0, 7, 28
|
TNFa Kinoid dose 2: Experimental |
Biological: TNFa Kinoid
TNFa kinoid at days 0, 7, 28
|
TNFa Kinoid dose 3: Experimental |
Biological: TNFa Kinoid
TNFa kinoid at days 0, 7, 28
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pierre Vandepapeliere, MD, PhD | +33(0)153102640 | pvandepapeliere@neovacs.com |
South Africa | |
Parexel George | Recruiting |
George, South Africa | |
Contact: Dawie Kruger, MD | |
Principal Investigator: Dawie Kruger, MD | |
Farmovs Parexel | Not yet recruiting |
Bloemfontein, South Africa | |
Contact: François Burger, MD | |
Principal Investigator: François Burger, MD | |
South Africa, Eastern Cape | |
Parexel Port Elizabeth | Recruiting |
Port Elizabeth, Eastern Cape, South Africa | |
Contact: Benji Pretorius, MD | |
Contact: Frans-Peter Botha, MD | |
Principal Investigator: Benji Pretorius, MD | |
Switzerland | |
Universitätsspital Zürich | Not yet recruiting |
Zurich, Switzerland | |
Contact: Gerhard Rogler, MD, PhD | |
Principal Investigator: Gerhard Rogler, MD | |
Centre Hospitalier Universitaire Vaudois | Not yet recruiting |
Lausanne, Switzerland | |
Contact: Pierre Michetti, MD, PhD | |
Principal Investigator: Pierre Michetti, MD, PhD |
Study Director: | Pierre Vandepapeliere, MD, PhD | Neovacs |
Responsible Party: | Neovacs SA ( Pierre Vandepapeliere, CMO ) |
Study ID Numbers: | TNFa-K-001 |
Study First Received: | December 12, 2008 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00808262 |
Health Authority: | South Africa: Medicines Control Council |
anti-TNFa immunization kinoid crohn's disease |
Digestive System Diseases Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases |