A Multicenter Study to Evaluate Safety and Efficacy of Specific Immunotherapy With Modified Allergen Extracts
NCT ID: NCT01012752
Last Updated: 2015-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
150 participants
INTERVENTIONAL
2016-10-31
2017-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Efficacy and Safety of Specific Immunotherapy With Modified Allergen Extracts of House Dust Mites
NCT01013116
Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy
NCT01014325
Dose-response Study With Subcutaneous Immunotherapy of an Standardized Dermatophagoides Pteronyssinus (DPT) Extract
NCT01564017
Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Mite Allergy
NCT02661854
Phase II Trial With Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense
NCT01567306
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
modified allergen extract
modified allergen extract
subcutaneous injections
Placebo
Placebo
subcutaneous injections
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
modified allergen extract
subcutaneous injections
Placebo
subcutaneous injections
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Positive screening skin prick test (wheal diameter \> 3 mm)
* Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
* Signed and dated patient´s Informed Consent,
Exclusion Criteria
* Simultaneous participation in other clinical trials,
* Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
* Auto-immune disorders,
* Severe chronic inflammatory diseases,
* Malignancy,
* Alcohol abuse,
* Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
* Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Roxall Medizin
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hamburg, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Roxall Medizin
Role: CONTACT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SBC-2009-003B
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.