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van CCT (UK)


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van CCT (UK)


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.


- candidate number2060
- NTR NumberNTR659
- ISRCTNISRCTN64619216
- Date ISRCTN created7-jun-2006
- date ISRCTN requested16-mei-2006
- Date Registered NTR21-apr-2006
- Secondary IDsN/A 
- Public TitleA 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.
- Scientific TitleA 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.
- ACRONYMAP IBD 02-01
- hypothesisUlcerative colitis is characterized by abnormal activation of the colon epithelium, which is considered to be a central pathogenic mechanism. Activation of colon epithelium cells in UC is associated with an abnormal high expression of Toll-like receptors, including TLR-4, the major transducer of LPS, binding specifically the lipid A portion of LPS. Alkaline Phosphatase binds and subsequently dephosphorylates LPS, thereby eliminating the ability of LPS to activate TLR-4.
This is expected to
1. prevent activation of the intestinal epithelium and
2. prevent systemic inflammatory responses that result from transmigration of endotoxin though the leaky inflamed intestinal mucosa.
Therefore, it is expected that administration of CIAP may attenuate or prevent the local and systemic inflammatory response in patients with fulminant ulcerative colitis.
- Healt Condition(s) or Problem(s) studiedFulminant ulcerative colitis
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 6-dec-2006
- planned closingdate31-dec-2007
- Target number of participants20
- InterventionsSubjects will receive 30.000 U AP/24 hrs for 7 consecutive days via a duodenal catheter.
- Primary outcomeSafety and tollerability.
- Secondary outcome1. 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).
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESM.D. B.Th.M. Bierman
- CONTACT for SCIENTIFIC QUERIESMD, PhD. G. Dijkstra
- Sponsor/Initiator AM-Pharma B.V.
- Funding
(Source(s) of Monetary or Material Support)
AM-Pharma
- PublicationsN/A
- Brief summaryTo study the safety and effect of Calf Intestinal Alkaline Phosphatase in patients with fulminant Ulcerative Colitis refractory to steroid therapy a simple open label design has been chosen to be conducted at three centers in the Netherlands. Subjects will receive 30.000 U CIAP/24 hrs for 7 consecutive days via a duodenal catheter. It is expected that administration of CIAP may attenuate or prevent the local and systemic inflammatory response in patients with fulminant ulcerative colitis. Patients will be followed for 9 weeks (63 days) after the start of study medication. Eligible patients will be hospitalized during the study period, and will be either dismissed upon partial recovery or after colectomy. The total study related follow up period is 9 weeks. A rescue procedure will be in place in case the clinical situation deteriorates.
- Main changes (audit trail)
- RECORD21-apr-2006 - 1-feb-2010


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