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Clinical Trials/EUCTR2009-014582-51-DE
EUCTR2009-014582-51-DE
Active, not recruiting
Not Applicable

Pilot study - sequential combination therapy using selective immunoglobulin apheresis and omalizumab in patients with severe atopic dermatitis and elevated total IgE levels

Faculty of Medicine, Technische Universität München0 sitesOctober 12, 2009
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ConditionsPatients with severe Atopic dermatitis and total IgE-level > 700 IU/ml (potentially associated with bronchial asthma and/or allergic rhinitis)MedDRA version: 12.0Level: LLTClassification code 10002198Term: Anaphylactic reactionMedDRA version: 12.0Level: LLTClassification code 10040400Term: Serum sicknessMedDRA version: 12.0Level: LLTClassification code 10043554Term: ThrombocytopeniaMedDRA version: 12.0Level: LLTClassification code 10019211Term: HeadacheMedDRA version: 12.0Level: LLTClassification code 10028810Term: NasopharyngitisMedDRA version: 12.0Level: LLTClassification code 10040753Term: SinusitisMedDRA version: 12.0Level: LLTClassification code 10022000Term: InfluenzaMedDRA version: 12.0Level: LLTClassification code 10006451Term: BronchitisMedDRA version: 12.0Level: LLTClassification code 10017888Term: GastroenteritisMedDRA version: 12.0Level: LLTClassification code 10034835Term: PharyngitisMedDRA version: 12.0Level: LLTClassification code 10047461Term: Viral infectionMedDRA version: 12.0Level: LLTClassification code 10034844Term: Pharyngolaryngeal painMedDRA version: 12.0Level: LLTClassification code 10011224Term: CoughMedDRA version: 12.0Level: LLTClassification code 10039083Term: RhinitisMedDRA version: 12.0Level: LLTClassification code 10028735Term: Nasal congestionMedDRA version: 12.0Level: LLTClassification code 10039085Term: Rhinitis allergicMedDRA version: 12.0Level: LLTClassification code 10012727Term: DiarrheaMedDRA version: 12.0Level: LLTClassification code 10028813Term: NauseaMedDRA version: 12.0Level: LLTClassification code 10013946Term: DyspepsiaMedDRA version: 12.0Level: LLTClassification code 10003988Term: Back painMedDRA version: 12.0Level: LLTClassification code 10003239Term: ArthralgiaMedDRA version: 12.0Level: LLTClassification code 10028411Term:
DrugsOmalizumab

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients with severe Atopic dermatitis and total IgE-level > 700 IU/ml (potentially associated with bronchial asthma and/or allergic rhinitis)
Sponsor
Faculty of Medicine, Technische Universität München
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 12, 2009
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Faculty of Medicine, Technische Universität München

Eligibility Criteria

Inclusion Criteria

  • •\- Diagnosis of severe atopic dermatitis (potentially associated with bronchial asthma and/or allergic rhinitis)
  • •\- Total serum IgE level \> 700 IU/ml
  • •\- SCORAD \> 50 within the last 12 months
  • •\- resistance or relapse to/after at least 2 systemic treatment modalities for atopic dermatitis
  • •\- No parallel systemic therapies during the omalizumab treatment period
  • •\- Adults \> 18 years of age
  • •\- Both parents of Caucasian heritage
  • •\- Residence in the greater Munich area
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:

Exclusion Criteria

  • •\- other chronic dieseases such as diabetes, hematological disorders etc.
  • •\- autoimmune diseases
  • •\- Cardiopulmonary/cardiovascular diseases
  • •\- Allergies against any of the used material or IMP
  • •\- Systemic infections (such as HIV\-infection etc)
  • •\- Systemic medication other than contraceptives
  • •\- Pregnancy
  • •\- Breast feeding (nursing)
  • •\- Parasitic infections
  • •\- Planed or recent travel to regions endemic for parasitic infections

Outcomes

Primary Outcomes

Not specified

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