Inflammatory Blowel Disease MedDRA version: 6.1 Level: PT Classification code 10009900
Conditions
Interventions
Product Name: Bovine-Calf Alkaline Phosphatase BIAP
Product Code: BIAP
Pharmaceutical Form: Oral solution
CAS Number: 9001-78-9
Concentration unit: IU international unit(s)
Concentration type: equa
Sponsors
AM PHARMA B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed