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NCT00263549 Clinical Trial

Safety and Efficacy of House Dust Mite Allergen Extract in the Treatment of Allergic Rhinoconjunctivitis

House Dust Mite Allergy Clinical Trial

Official title:
Multicenter Study for Evaluation of Efficacy and Safety of Perennial Specific Immunotherapy With a Depot House Dust Mite Allergen Extract (D. Pteronyssinus 100%) in Patients With House Dust Mite Sensitivity

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00263549
Other study ID # Al0201NH
Secondary ID
Status Completed
Phase Phase 4
First received December 8, 2005
Last updated February 8, 2013
Start date September 2002
Est. completion date February 2006

Study information
Verified date February 2013
Source Allergopharma GmbH & Co. KG
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial Summary

The trial is performed to assess efficacy and safety of Novo-Helisen Depot in allergic Rhinoconjunctivitis

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date February 2006
Est. primary completion date February 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Positive skin prick test to house dust mite,

- Positive RAST test to house dust mite,

- Positive provocation test result to house dust mite,

Exclusion Criteria:

- Serious chronic diseases,

- Other perennial allergies

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• House dust mite Novo Helisen Depot

Locations
Country Name City State
Germany Allergopharma GmbH & Co. KG Reinbek

Sponsors (1)
Lead Sponsor Collaborator
Allergopharma GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

See also
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Completed NCT01923792 - ToleroMune House Dust Mite Follow on Study N/A
Completed NCT01930461 - Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma Phase 2
Completed NCT00574704 - A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis Phase 2
Completed NCT05019209 - Skin Responses and T Cell Immunology After House Dust Mite Exposure in Sensitized Atopic Dermatitis Patients N/A
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Completed NCT01454544 - A One Year Trial Evaluating the Safety and Efficacy of the ALK House Dust Mite Allergy Tablet Phase 3
Terminated NCT01777464 - Role of the Central Nervous System in Allergic Rhinitis N/A
Completed NCT00574223 - A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis Phase 2
Completed NCT02345278 - SUBLIVAC FIX Mite Mixture Dose Tolerability Study Phase 1/Phase 2
Completed NCT01608243 - Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts Phase 1
Completed NCT04435678 - Diagnostic Accuracy of the MADx Multi Array Xplorer (MAX 45k) Automated Laboratory System and the MADx Allergy Explorer Version 2 (ALEX²) - IgE Multiplex Test for the Diagnosis of Pre-defined Groups of Specific High-priority Allergens N/A
Completed NCT01134757 - Safety of Bronchial Allergen Challenge and Predictors for Positive Reaction. N/A
Recruiting NCT05395689 - Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM Phase 3
Not yet recruiting NCT05400811 - Efficacy and Safety Evaluation for the Treatment of HDM Induced Allergic Asthma and Rhinitis/Rhinoconjunctivitis Phase 3
Not yet recruiting NCT05450289 - The Efficacy of Nigella Sativa in Children With House Dust Mite-Induced Respiratory Allergy Receiving Immunotherapy N/A
Recruiting NCT05174689 - Epigenetic Regulation of Exercise Induced Asthma N/A
Terminated NCT04874714 - Efficacy and Safety Evaluation for the Treatment of Asthma and Allergic Rhinitis/Rhinoconjunctivitis Phase 3
Completed NCT00380926 - Fish Oil and Asthma in House Dust Mite Allergy Phase 2/Phase 3

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