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Bovine Intestinal Alkaline Phosphatase for the Treatment of Patients With Sepsis

NCT00430859 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2012-04-02

No results posted yet for this study

Summary

Eligible patients will receive either AP or matching placebo in a double blind, randomized design and following a 2:1 ratio. All medication will be given in addition to standard care for sepsis patients. Patients will be followed for 28 days after the start of study medication administration. A blinded safety review of the study results will take place after the inclusion of 12 patients in the study.

Conditions

  • Sepsis
  • Multiple Organ Dysfunction Syndrome

Interventions

DRUG

Alkaline Phosphatase

Intravenous over a period of 24 hours

DRUG

Placebo

Saline over a period of 24h

Sponsors & Collaborators

  • AM-Pharma

    lead INDUSTRY

Principal Investigators

  • Bart Wuurman, M.Sc.

  • Hans JG van der Hoeven, MD, PhD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2006-03-31
Completion
2006-03-31

Countries

  • Belgium
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
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 NCT00430859 on ClinicalTrials.gov