Inflammatory Bowel Disease
Conditions
Interventions
Product Name: Bovine-Calf Alkaline Phosphatase (BIAP)
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
AM-Pharma B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · age ³ 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 7-15 or · 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, andchronic 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
Exclusion criteria
Exclusion criteria: § ulcerative colitis, requiring immediate surgical, endoscopic, or radiological intervention; · 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 screening 2. 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 baseline 3. probiotics, antibiotics, methotrexate or cyclosporine within 1 month resp. 2 months prior of screening 4. any experimental treatment for this population e.g. infliximab, tacrolimus, FK506 or other anti TNF-a therapy) within 2 months of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the safety and tolerability of BIAP 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 colitis Safety variables Evaluation of circulating antibodies against BIAP, via ELISA Clinical labs (hematology/chemistry incl. cytokines/urine) Vital signs, physical examinations Adverse event monitoring. | — |
Countries
Czech Republic, Italy
Outcome results
None listed