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A Randomized, Prospective, Double-Blinded, Placebo-Controlled (Sham-Controlled) Study to Evaluate the Safety and Effectiveness of the Adacolumn Apheresis System for the Treatment of Moderate to Severe

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Trial Conditions
  • Ulcerative Colitis
What is the purpose of this trial?

The purpose of this study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18  - 75 

Gender:
Both

Eligibility

Key Inclusion Criteria:

- Moderate to severe active ulcerative colitis with colonic involvement with ulcerative
colitis beyond 15 cm of the anal verge

- Adequate peripheral venous access to allow for completion of the apheresis treatments

- Receiving one or more of the following medical therapies:

*sulfasalazine, *mesalamine and other 5-ASA agents, *prednisone or 6-mercaptopurine
or azathioprine OR Have not received the above medical therapies due to intolerance
or demonstrated non-response

- 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 Criteria:

- Evidence of toxic megacolon

- Major surgery within the past 6 weeks or anticipated need for surgery within 12 weeks

- Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis

- 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

- Insulin-dependent Type I or Type II diabetes

- 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

Gender: Both
Steward Physician(s)
  • Yosuke Komatsu, MD, PhD
Facilities
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Device
  • Adacolumn Apheresis System
Physician Researcher

Investigator Name:

  • Yosuke Komatsu, MD, PhD

Other Information

Sponsor: Otsuka America Pharmaceutical
Phase: Phase 3
Trial ID: NCT00102193
Volunteers:  Not Accepting Healthy Volunteers

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