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Safety/Efficacy Study of Bovine Intestinal Alkaline Phosphatase in Patients With Moderate to Severe Ulcerative Colitis

NCT00727324 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2012-04-02

No results posted yet for this study

Summary

Ulcerative colitis is characterized by abnormal activation of, and damage to, 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 BIAP may attenuate or prevent the local and systemic inflammatory response in patients with severe ulcerative colitis.

Conditions

Interventions

DRUG

bovine intestinal alkaline phosphatase (BIAP)

30,000U/24h for 7 consecutive days via a duodenal catheter

Sponsors & Collaborators

  • CRM Biometrics GmbH

    collaborator INDUSTRY

  • Sintesi Research Srl

    collaborator INDUSTRY

  • Vigilex BV

    collaborator UNKNOWN

  • AM-Pharma

    lead INDUSTRY

Principal Investigators

  • Prof Milan Lukas, PhD, MD · University Prague, Czech Republic

  • Prof Paolo Gionchetti, PhD, MD · Policlinico S. Orsola, Bologna, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2006-11-30
Completion
2006-12-31

Countries

  • Czechia
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00727324 on ClinicalTrials.gov