A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Calf Intestinal Alkaline Phosphatase in patients with moderate to severe ulcerative colitis - AP IBD 02-02
- Conditions
- Inflammatory Blowel DiseaseMedDRA version: 6.1Level: PTClassification code 10009900
- Registration Number
- EUCTR2006-000197-69-IT
- Lead Sponsor
- AM PHARMA B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 24
age 18 years, and capable of understanding the purpose and risks of the study and have provided a signed and dated written informed consent, and prior to the study baseline, been treated with oral steroid medication, of which 2 weeks on oral prednisone equivalent of at least 40 mg/day, and still have active ulcerative colon disease documented by a MAYO-score of 6-11, and active ulcerative colon disease documented by a MTWSI score of 7-15 or prior to the study baseline, documented clinical inability to decrease or stop the course of oral steroid medication. Patients have been treated for a minimum of 12 weeks, and still have chronic active ulcerative colon disease documented by a MAYO-score of 6-11, and chronic active ulcerative colon disease documented by a MTWSI score of 7-15or prior to the study baseline, been treated with a stable dosage of azathioprine for a minimum of 12 weeks, and have a moderate to severe relapse defined as chronic active ulcerative colon disease documented by a MAYO-score of 6-11, and chronic active ulcerative colon disease documented by a MTWSI score of 7-15
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
ulcerative colitis, requiring immediate surgical, endoscopic, or radiological intervention; including massive hemorrhage, perforation and sepsis, suppurative complications intra-abdominal or peri-anal abscesses or toxic colon history of large bowel surgery history of serious infections positive stool cultures, including Clostridium Difficile significant organ dysfunction pregnancy, nursing mothers, or women of childbearing potential without appropriate use of contraceptives treatment with 1. an altered dose of any 5-ASA preparation within 4 weeks of screening2. an altered dose of azathioprine or mercaptopurine within 4 weeks of screening stable dosage of immunosuppressives is allowed , or start of azathioprine in the last 3 months prior to baseline3. probiotics, antibiotics, methotrexate or cyclosporine within 1 month resp. 2 months prior of screening4. any experimental treatment for this population e.g. infliximab, tacrolimus, FK506 or other anti TNF- 945; therapy within 2 months of screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the safety and tolerability of 7 days of BIAP administration in patients with moderate to severe ulcerative colitis;Secondary Objective: To investigate the efficacy of BIAP in patients with moderate to severe ulcerative colitis;Primary end point(s): To investigate the safety and tolerability of 7 days of BIAP administration in patients with moderate to severe ulcerative colitisSafety variables Evaluation of circulating antibodies against BIAP, via ELISA Clinical labs hematology/chemistry incl. cytokines/urine Vital signs, physical examinations Adverse event monitoring.
- Secondary Outcome Measures
Name Time Method