Status:
COMPLETED
Adacolumn in Refractory UC Patients Trial
Lead Sponsor:
Otsuka Pharmaceutical Europe Ltd
Conditions:
Ulcerative Colitis, Active Moderate
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The objectives of the study are to observe and document the efficacy and safety of 5 or more Adacolumn treatments, administered once weekly over 5 or more weeks, in a specific subset of ulcerative col...
Eligibility Criteria
Inclusion
- Patients enrolled into the study will be between 18 and 75 years old and have moderate to severe, steroid-dependent, active ulcerative colitis documented by clinical symptoms, endoscopic findings and histology. Patients will have an ulcerative colitis clinical activity (CAI) of ≥6 and an endoscopic activity index (EAI) of ≥4. Patients will have an insufficient response or intolerance to immunosuppressants and/or biological treatment agents. Patients are required to have adequate peripheral venous access to allow completion of apheresis treatment.
Exclusion
- \- A patient will be excluded from the study if he/she meets any of the following criteria:
- Is febrile (body temperature \>38ºC).
- Has evidence of toxic megacolon.
- Has known obstructive disease of the gastrointestinal system.
- Is anticipated to need surgery within the next 24 weeks.
- Has a history of hypersensitivity reaction associated with an apheresis procedure or an intolerance to apheresis procedures.
- Has proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis.
- Has a history of allergic reaction to heparin or of heparin-induced thrombocytopenia.
- Has a known infection with enteric pathogens, pathogenic ova or parasites, or a positive test for cytomegalovirus.
- Has symptomatic hypotension.
- Has a history of physical findings consistent with a cerebrovascular accident.
- Has a history of myocardial infarction or unstable angina within the previous 6 months.
- Has undergone coronary artery bypass graft surgery or angioplasty within the previous 6 months.
- Has congestive heart failure (New York Heart Association Class III or IV).
- Has a prosthetic heart valve, pacemaker or other permanent implant.
- Has severe cardiovascular or peripheral vascular disease.
- Has liver disease defined as levels of aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT) or alkaline phosphatase of greater than 2.5 × the upper limit of the normal range for the laboratory performing the test.
- Has a history of cirrhosis.
- Has a known bleeding disorder (prothrombin time \[PT\] or partial thromboplastin time \[PTT\] greater than 1.5 × the upper limit of the normal range for the laboratory performing the test) or requires concomitant anticoagulant therapy for purposes other than apheresis treatment.
- Has a prior history suggestive of a hypercoagulable disorder, including 1 or more episodes of pulmonary embolism or deep vein thrombosis.
- Has a known infection with hepatitis B or C or human immunodeficiency virus.
- Has abnormal haematology parameters defined as severe anaemia with haemoglobin \<8.5 g/dL, white blood cell count \<3500/µL or granulocyte count \<2000/µL.
- Has a fibrinogen level \>700 mg/dL.
- Has renal insufficiency, defined as a serum creatinine level greater than 150% of the upper limit of the normal range for the laboratory performing the test.
- Has had major surgery within the previous 6 weeks.
- Has any of the following types of infection:
- An active infection within 4 weeks of successful completion of antibiotic treatment for a bacterial infection.
- Febrile viral infection within the 4 weeks prior to entry into the study.
- Systemic fungal infection that required therapy which was completed within the 12 weeks prior to entry into the study.
- Current drug or alcohol abuse.
- Is pregnant, lactating or planning to become pregnant during the study.
- Has used an investigational medicinal product, biologic agent or device within the last 30 days.
- Adults lacking capacity who are unable to give consent by themselves due to physical and or mental incapacity.
- Prisoners and patients who have undergone psychiatric treatment.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01481142
Start Date
October 1 2011
End Date
July 1 2015
Last Update
October 19 2015
Active Locations (1)
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1
Clinique Universitaire d'Hépato-Gastroentérologie
Grenoble, France, 38 043