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Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)

NCT04037176 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-12-05

No results posted yet for this study

Summary

Food allergy is a common disease in childhood affecting up to 8% of children in Westernized countries. About 30 percent of children with food allergies are allergic to more than one food, most often milk, egg, wheat, peanut and tree nut. Peanut and hazelnut are common triggers of severe and potentially fatal food-induced anaphylactic reactions. Currently, there is no curative treatment for food allergy. Novel therapies for this potentially life-threatening condition are therefore much needed.

Conditions

Interventions

DRUG

Omalizumab

Subcutaneous administration every 2. week or every 4. week. Dose is depending of the patients weight and IgE

OTHER

Placebo

Subcutaneous administration every 2. week or every 4. week. Dose is depending of the patients weight and IgE

Sponsors & Collaborators

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • Thermo Fisher Scientific, Inc

    collaborator INDUSTRY

  • Carsten Bindslev-Jensen

    lead OTHER

Principal Investigators

  • Carsten Bindslev-Jensen, Prof DM PhD · Odense Research Center For Anaphylaxis

  • Susanne Halken, Prof DM MD · Department of Childrens Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2022-03-15
Completion
2022-03-15

Countries

  • Denmark

Study Locations

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Entities

Diseases
Companies

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 NCT04037176 on ClinicalTrials.gov