Status:
COMPLETED
CESA 5.10 Investigation to Compare the Efficacy and Safety of the Adacolumn® Apheresis Device in Patients With Active Ulcerative Colitis
Lead Sponsor:
Otsuka Frankfurt Research Institute GmbH
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to compare the safety and efficacy of 5 Adacolumn® treatments over 5 weeks to 10 treatments (two Adacolumn® apheresis treatments during the first 2 weeks, followed by 6 we...
Eligibility Criteria
Inclusion
- 18-75 years old
- Active ulcerative colitis documented by clinical symptoms, endoscopic findings and histology (in patient history)
- Moderate to severe active ulcerative colitis at baseline evaluation, defined as follows:
- Clinical activity idex (CAI) score \> 6; and
- Stool frequency score of 2 or 3
- Colonic involvement with ulcerative colitis beyond 15 cm of the anal verge
- Ulcerative colitis for at least 3 months
- Adequate peripheral venous access to allow for completion of the apheresis treatments, as demonstrated by the ability to successfully undergo a brief venous access procedure
- Receiving one or more of the following medical therapies:
- Sulfasalazine, mesalamine and other 5-aminosalicylic acid (5-ASA) agents for 4 weeks or more with a stable dose for the last 2 weeks
- A maximum of 20 mg per day of prednisone with a stable dose for the last 2 weeks, or
- 6-mercaptopurine or azathioprine for 12 weeks or more with a stable dose for the last 4 weeks; OR
- Have not received the above medical therapies due to intolerance or demonstrated non-response for the time periods specified below:
- Sulfasalazine, mesalamine and other 5-ASA agents for 2 weeks
- Prednisone for 2 weeks, or
- 6-mercaptopurine or azathioprine for 4 weeks
- For female subjects of child-bearing potential, a negative pregnancy test and agreement to use an effective contraceptive method or abstain from sexual intercourse during the course of the clinical investigation
- Agree to participate in the required follow-up visits
- Able to complete the diary
- Signed written informed consent document
Exclusion
- Febrile (\> 38ºC)
- Evidence of toxic megacolon
- Anticipated need for surgery within 12 weeks
- Known obstructive diseases of the gastrointestinal system
- Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis
- 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
- Requires a central venous access catheter for the apheresis treatments
- Known infection with enteric pathogens, pathogenic ova or parasites, or a positive assay for C. difficile toxin
- Hypotension (systolic blood pressure \< 90 mmHg and/or diastolic blood pressure \< 65 mmHg) at screening visit only
- Uncontrolled hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 120 mmHg) despite medical therapy at screening visit only
- A history of myocardial infarction or unstable angina within the past 6 months
- A history of coronary artery bypass grafting surgery or angioplasty within the past 6 months
- A history of physical findings compatible with a cerebrovascular accident
- Congestive heart failure (New York Heart Association Class III or IV)
- Prosthetic heart valve, pacemaker or other permanent implant
- Severe cardiovascular or peripheral vascular disease
- Liver disease defined as levels of SGOT \[AST\], SGPT \[ALT\] or alkaline phosphatase \> 2.5x the upper limit of the normal range for the laboratory performing test
- History of cirrhosis
- Renal insufficiency, defined as serum creatinine \> 150% of the upper limit of the normal range for the laboratory performing the test
- Insulin-dependent type I or type II diabetes. (Patients receiving oral antidiabetic treatment can be included.)
- Known bleeding disorder (PT or PTT \> 1.5x the upper limit of the normal range for the laboratory performing the test), or concomitant anticoagulant therapy for purposes other than apheresis treatment
- Prior history suggestive of a hypercoagulable disorder, including 1 or more episodes of pulmonary embolism or deep vein thrombosis
- Known infection with hepatitis B or C, or HIV
- Abnormal hematology parameters defined as severe anemia with hemoglobin \< 8.5 g/dL, white blood cell count of \< 3,500/ul and a granulocyte count \< 2,000/μl
- Fibrinogen level \> 700 mg/dL
- Major surgery within the past 6 weeks
- Infection:
- Active infections less than 4 weeks from successful completion of antibiotic treatment for routine bacterial infection
- Febrile viral infection within 4 weeks of entry into the clinical investigation
- Less than 12 weeks from conclusion of therapy for systemic fungal infections
- Malignancy within the past 2 years other than surgically cured skin carcinoma or cervical dysplasia (CIN I-II)
- History of dysplasia or carcinoma of the colon
- Current drug or alcohol abuse
- Pregnant, lactating or planning to become pregnant during the course of the clinical investigation
- Used within the last 30 days, an investigational drug, biologic or device or 5 half lives, if known, for any investigational drug or biologic
- Received cyclosporine or tacrolimus within the last 4 weeks
- Received infliximab within the last 8 weeks
- Received oral budesonide within the last 2 weeks
- Used topical therapy for ulcerative colitis within the last 2 weeks
- Previously received Adacolumn® treatments
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2008
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT00366925
Start Date
April 1 2006
End Date
July 1 2008
Last Update
April 28 2009
Active Locations (1)
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1
Markus-Krankenhaus
Frankfurt am Main, Hesse, Germany, 60431