Status:
COMPLETED
Study for the Treatment of Crohn's Disease With Adacolumn
Lead Sponsor:
Otsuka America Pharmaceutical
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the Adacolumn Apheresis System as a treatment for the signs and symptoms of Crohn's disease.
Detailed Description
Trial Features: * Medical device (Non-drug option) * Most patients can remain on current treatment regimen throughout the study Components of the Study: * Study length is 24 weeks, which includes a...
Eligibility Criteria
Inclusion
- Key
- Moderate to severe Crohn's disease
- Adequate peripheral venous access
- Agree to participate in the required follow-up visits
- Able to complete a diary
- Signed written informed consent document and authorization for use of protected health information
- Key
Exclusion
- Extremely severe Crohn's disease
- Known obstructive symptoms within the past 3 months
- Presence of toxic megacolon
- Major surgery within the past 6 weeks or anticipated need for surgery within 12 weeks
- Total colectomy, ileostomy, stoma or 100 cm of resected small bowel
- Requiring in-patient hospitalization
- A history of allergic reaction to heparin or heparin-induced thrombocytopenia
- A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures
- A history of severe cardiovascular or peripheral arterial diseases
- A history of cerebral vascular diseases
- Liver diseases
- Renal insufficiency
- Known bleeding disorder or use of concomitant anticoagulant therapy for purposes other than apheresis treatment
- Any hypercoagulable disorder
- Known infection with Hepatitis B or C, or HIV
- Severe anemia
- Leukopenia or granulocytopenia
- Evidence of current systemic infection
- Malignancy
- Pregnant, lactating or planning to become pregnant during the course of the investigational study
- Used within the last 30 days, an investigational drug, biologic or device or 5 half-lives, if known, for any investigational drug or biologic
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT00162942
Start Date
January 1 2005
End Date
December 1 2007
Last Update
April 7 2009
Active Locations (37)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic Scottsdale
Phoenix, Arizona, United States, 85054
2
Capitol Gastroenterology Consultants Medical Group
Roseville, California, United States, 95661-3037
3
UCSF Mount Zion Medical Center
San Francisco, California, United States, 94115
4
Rocky Mountain Gastroenterology Associates, PC
Wheat Ridge, Colorado, United States, 80033