A pilot, open-label, multicentre study to investigate the safety of calf intestine alkaline phosphatase in patients with fulminant active ulcerative colitis refractory to steroid therapy

AM-Pharma B.V. (The Netherlands)0 sites20 target enrollmentJune 7, 2006

Overview

No summary available.

Registry

who.int

Start Date

June 7, 2006

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

AM-Pharma B.V. (The Netherlands)

•1\. Patients between 18 and 70 years (inclusive)
•2\. A diagnosis of UC verified by colonoscopy and confirmed by histology
•3\. Active disease documented by a Modified True Love and Witts Severity Index (MTWSI) score of 11\-21, despite an ongoing treatment course of intravenous steroids for a minimum of 3 days prior to the study; a stool frequency \>8 stools or a stool frequency between 3 and 8 and a C\-reactive protein (CRP) \>45 mg/l (Travis criteria)
•4\. Women of childbearing potential who have a negative serum pregnancy test at baseline screening
•5\. Patients must have tested negative for stool cultures including Clostridium difficile
•6\. Patients who are capable of understanding the purpose and risks of the study and who provide a signed and dated written informed consent

•1\. UC requiring immediate surgical, endoscopic, or radiological interventions, including massive hemorrhage, perforation and sepsis, suppurative complications (intra\-abdominal or peri\-anal abscesses) or toxic colon
•2\. History of large bowel surgery
•3\. Patients with serious infections
•4\. Significant organ dysfunction
•5\. Pregnant women or nursing mothers
•6\. Concomitant medications:
•a.. Altered dose of any 5\-aminosalicylates (5\-ASA) preparation within two weeks of screening
•b. Altered dose of azathioprine or mercaptopurine within four weeks of screening
•c. Patients who have started azathioprine in the last three months prior to baseline
•d. Received probiotic, antibiotics or cyclosporine within 1 month or 2 months respectively prior of screening