A pilot, open-label, multi-centre study to investigate the safety of Calf Intestinal Alkaline Phosphatase in patients with fulminant active ulcerative colitis refractory to steroid therapy.
Completed
- Conditions
- Fulminant ulcerative colitis
- Registration Number
- NL-OMON21005
- Lead Sponsor
- AM-Pharma B.V.Rumpsterweg 63981 AK BunnikTHE NETHERLANDSTelephone: +31 (0)30 228 9 222Telefax: +31 (0)30 228 9 220
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1. Patients between 18 and 70 years (inclusive) of age;
2. A diagnosis of UC verified by colonoscopy and confirmed by histology;
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tollerability.
- Secondary Outcome Measures
Name Time Method 1. Rescue medication including ciclosporin,<br>experimental medication such as anti-CD-3 antibodies or colectomy rate at 9 weeks (63 days);<br /> <br>2. Clinical response based on change in the MTWI for disease activity between baseline-day 15 clinical, endoscopical and serological, activity scores at baseline and after 1 week of treatment, including the Modified Truelove and Witts Severity Index, the Mayo score, colon biopsy samples;<br /><br>3. CRP plasma evels and stool markers of disease activity (calprotectin).