Fulminant ulcerative colitis
Conditions
Interventions
Subjects will receive 30.000 U AP/24 hrs for 7 consecutive days via a duodenal catheter.
Sponsors
AM-Pharma B.V.
Rumpsterweg 6
3981 AK Bunnik
THE NETHERLANDS
Telephone: +31 (0)30 228 9 222
Telefax: +31 (0)30 228 9 220
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients between 18 and 70 years (inclusive) of age; 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 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 provided a signed and dated written informed consent.
Exclusion criteria
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-ASA preparation within 2 weeks of screening; b. Altered dose of azathioprine or mercaptopurine within 4 weeks of screening; c. Patients who have started azathioprine in the last 3 months prior to baseline; d. Received probiotic, antibiotics or cyclosporine within 1 month resp 2 months prior of screening; e. Received any experimental treatment for this population e.g. infliximab, tacrolimus, FK506) within 2 months of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tollerability. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rescue medication including ciclosporin, experimental medication such as anti-CD-3 antibodies or colectomy rate at 9 weeks (63 days); 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; 3. CRP plasma evels and stool markers of disease activity (calprotectin). | — |
Contacts
Public ContactB.Th.M. Bierman
AM-Pharma B.V., Rumpsterweg 6
Outcome results
None listed