The Effect of Autologous Autovaccine in Patients With Allergy on House-dust-mite (FIAVS)
This study has been completed.
Sponsor:
Johann Wolfgang Goethe University Hospitals
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00677209
First received: May 12, 2008
Last updated: December 28, 2010
Last verified: May 2008
| Tracking Information | |||||
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| First Received Date ICMJE | May 12, 2008 | ||||
| Last Updated Date | December 28, 2010 | ||||
| Start Date ICMJE | July 2006 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00677209 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Lung function,exhalative NO [ Time Frame: jul 2006 - oct 2007 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effect of Autologous Autovaccine in Patients With Allergy on House-dust-mite | ||||
| Official Title ICMJE | Frankfurt Investigator-initiated Autovaccine-study | ||||
| Brief Summary | House dust mite allergy is a common problem, resulting in asthma, chronic swelling of the eyes, and running nose. The investigators test a possibility to immunize subjects sensitized against house dust mite with extracts from their own gut bacteria "auto-vaccination". |
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| Detailed Description | see above |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Allergens, House Dust Mites | ||||
| Intervention ICMJE | Biological: Injection of autovaccine (Autovaccine Symbiopharm)
increasing dosage schedule, six different concentrations, application over six weeks, 2 weeks break, another six weeks, 2 weeks break, than challenge with inhalative house dust mite extract
Other Name: Autovaccine Symbiopharm |
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| Study Arm (s) | Active Comparator: A
house dust mite allergics will undergo autovaccine immunization
Intervention: Biological: Injection of autovaccine (Autovaccine Symbiopharm) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 8 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 35 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00677209 | ||||
| Other Study ID Numbers ICMJE | AVH-2004/1, Eudra-CT Nr. 2005-005534-12 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Prof Stefan Zielen, Childrens Hospital Goethe University | ||||
| Study Sponsor ICMJE | Johann Wolfgang Goethe University Hospitals | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Johann Wolfgang Goethe University Hospitals | ||||
| Verification Date | May 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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