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

Completed

• Conditions: Fulminant ulcerative colitis; Digestive System; Ulcerative colitis unspecified

• Registration Number: ISRCTN64619216
• Lead Sponsor: AM-Pharma B.V. (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-07
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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
e. Received any experimental treatment for this population e.g. infliximab, tacrolimus, (FK506) within two months of screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified