A multi centre randomised placebo-controlled double-blind clinical trial for the evaluation of efficacy of specific immunotherapy with an aluminium hydroxide-adsorbed recombinant hypoallergenic derivative of the major birch pollen allergen r Bet v1-FV on Bet v 1 associated soy allergy (Birch Associated Soy Allergy and Immuno-Therapy)
Coordinating investigators: Prof. Dr. Jan C. Simon Prof. Dr. Regina Treudler Klinik für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Leipzig
Sponsor: Universität Leipzig Ritterstr. 26, 04109 Leipzig
Sponsor: Leipzig University (Sponsor)
SEEK ID: https://ldh.zks.uni-leipzig.de/projects/3
Funding codes:- Bundesministerium für Bildung und Forschung Förderkennzeichen: 01KG0911
Public web page: https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-011737-27/DE
ZKS Leipzig PIs: Prof. Dr. med. Jan C. Simon, Prof. Dr. med. Regina Treudler
Trial Project created: 3rd Apr 2023
Trial Project end date: 18th Jul 2014
- : Study
- : Birch Associated Soy Allergy and Immuno-Therapy
- : English
- : BASALIT
- : English
- : A multi centre randomised placebo-controlled double-blind clinical trial for the evaluation of efficacy of specific immunotherapy with an aluminium hydroxide-adsorbed recombinant hypoallergenic derivative of the major birch pollen allergen r Bet v1-FV on Bet v 1 associated soy allergy (Birch Associated Soy Allergy and Immuno-Therapy)
- : English
- : Not specified
- : Not specified
- Details about the contributing organisation(s)/institution(s)/group(s)
- : Not specified
- : Not specified
- : Not specified
- Details about the contributing person(s)
- : Not specified
- : Not specified
- : Not specified
- Digital identifier(s)
- : Not specified
- : Not specified
- : Not specified
- : Not specified
- Organisation(s) associated with the contributor
- : Not specified
- : Not specified
- : Not specified
- Digital identifier(s)
- : Not specified
- : Not specified
- : EudraCT
- : 2009-011737-27
- : Interventional
- Specification of the type of the Project
- : Parallel
- : []
- Primary health condition(s) or disease(s) considered in the Project
- : Birch pollen allergy
- : MedDRA
- : 10066093
- Groups of diseases or conditions(*)
- : Diseases of the blood or blood-forming organs and certain disorders involving the immune mechanism (III)
- : []
- : Not specified
- Administrative information about the Project
- : Not specified
- : Completed: Recruitment, data collection, and data quality management completed normally
- : Not specified
- : Not specified
- : 18 July 2014
- : Multicentric
- : 16
- : Not specified
- : Not specified
- : Not specified
- Eligibility criteria for Project participants
- Eligibility criteria: Minimum age
- : 18
- : Years
- Eligibility criteria: Maximum age
- : 65
- : Years
- : Male, Female
- : Not specified
- : Not specified
- Population of the Project(*)
- : Not specified
- : []
- : Not specified
- Interventions of the Project
- : Not specified
- : Not specified
- : Not specified
- : Not specified
- Exposures of the Project
- : Not specified
- : Not specified
- : Not specified
- : Not specified
- Outcome measures in the Project
- : Not specified
- : Not specified
- : Not specified
- : Not specified
- : Not specified
- : []
- Data sharing strategy of the Project(*)
- : Not specified
- : []
- : Not specified
- : Not specified
- : Not specified
- : No
- : Not specified
- : Not specified
- : Not specified
- Non-interventional aspects of the Project
- : []
- Target follow-up duration of the Project
- : Not specified
- : Not specified
- : Not specified
- : []
- : Not specified
- Interventional aspects of the Project
- : Not specified
- Masking of intervention(s) assignment
- : true
- : []
- : Not specified
- : Not specified
- : Not specified
Related items
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- GRAFT: Granulocyte colony stimulating factor (G-CSF) to treat acute-on-chronic liver failure
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- BASALIT: Birch Associated Soy Allergy and Immuno-Therapy
- AbCD: Antibody diagnostics in paediatric Coeliac Disease
Institutions: Zentrum für Klinische Studien Leipzig (ZKS Leipzig), Universität Leipzig
https://orcid.org/0000-0002-8706-217XTrial Projects:
- STOP-NUC: A multicentre randomized controlled trial evaluating the rate of sustained remission and the safety when stopping nucleos(t)ide analogue treatment in non-cirrhotic HBeAg-negative chronic Hepatitis B patients with long-term virologic response
- BASALIT: Birch Associated Soy Allergy and Immuno-Therapy
Institutions: Zentrum für Klinische Studien Leipzig (ZKS Leipzig), Universität Leipzig, Default Institution
https://orcid.org/0000-0001-8344-0658Trial Projects:
- BASALIT: Birch Associated Soy Allergy and Immuno-Therapy
- ADIPO-Vent: Optimierung der perioperativen maschinellen Ventilation bei adipösen und normalgewichtigen Patienten durch PEEP-Titration anhand der Elektrischen Impedanz-Tomografie
- GRAFT: Granulocyte colony stimulating factor (G-CSF) to treat acute-on-chronic liver failure
- AbCD: Antibody diagnostics in paediatric Coeliac Disease
- TIBICO: Effectiveness of TNI vs. BiPAP in Chronic Global Insufficiency in COPD Patients
- STOP-NUC: A multicentre randomized controlled trial evaluating the rate of sustained remission and the safety when stopping nucleos(t)ide analogue treatment in non-cirrhotic HBeAg-negative chronic Hepatitis B patients with long-term virologic response
Institutions: Zentrum für Klinische Studien Leipzig (ZKS Leipzig), Universität Leipzig
https://orcid.org/0000-0002-9256-7543For each clinical trial conducted according to the German Medicines Act (AMG) or the Medical Devices Act (MPG), a sponsor must be named who assumes overall responsibility for the clinical trial. In the case of human clinical trials initiated and managed by staff of the Medical Faculty of the University of Leipzig or Leipzig University Hospital (UKL) (Investigator Initiated Trials; IITs), the University of Leipzig assumes the function of sponsor if no third party is the sponsor.
Trial Projects:
- STOP-NUC: A multicentre randomized controlled trial evaluating the rate of sustained remission and the safety when stopping nucleos(t)ide analogue treatment in non-cirrhotic HBeAg-negative chronic Hepatitis B patients with long-term virologic response
- BASALIT: Birch Associated Soy Allergy and Immuno-Therapy
- ADIPO-Vent: Optimierung der perioperativen maschinellen Ventilation bei adipösen und normalgewichtigen Patienten durch PEEP-Titration anhand der Elektrischen Impedanz-Tomografie
- GRAFT: Granulocyte colony stimulating factor (G-CSF) to treat acute-on-chronic liver failure
- AbCD: Antibody diagnostics in paediatric Coeliac Disease
- TIBICO: Effectiveness of TNI vs. BiPAP in Chronic Global Insufficiency in COPD Patients
Country: Germany
City: Leipzig
Web page: https://www.uniklinikum-leipzig.de/einrichtungen/dermatologie
Just synthetic data from - no relation to BASALIT. Just Placeholder to show how data files can be explored in LDH.
Creator: Dr. Frank Meineke
Submitter: Dr. Frank Meineke
Abstract (Expand)
Authors: L. R. Caballero, R. Treudler, N. Delaroque, J. C. Simon, K. Kern, M. Szardenings
Date Published: 15th Sep 2022
Publication Type: Journal
PubMed ID: 36102274
Citation: Clin Exp Allergy. 2023 Mar;53(3):316-326. doi: 10.1111/cea.14224. Epub 2022 Sep 23.
Abstract (Expand)
Authors: R. Treudler, A. Franke, A. Schmiedeknecht, B. Ballmer-Weber, M. Worm, T. Werfel, U. Jappe, T. Biedermann, J. Schmitt, R. Brehler, A. Kleinheinz, J. Kleine-Tebbe, H. Bruning, F. Rueff, J. Ring, J. Saloga, K. Schakel, T. Holzhauser, S. Vieths, J. C. Simon
Date Published: 21st Dec 2016
Publication Type: Journal
PubMed ID: 27998002
Citation: Allergy. 2017 Aug;72(8):1243-1253. doi: 10.1111/all.13112. Epub 2017 Jan 17.
Abstract (Expand)
Authors: T. Holzhauser, A. Franke, R. Treudler, A. Schmiedeknecht, S. Randow, W. M. Becker, J. Lidholm, S. Vieths, J. C. Simon
Date Published: 18th Oct 2016
Publication Type: Journal
PubMed ID: 27748994
Citation: Mol Nutr Food Res. 2017 Mar;61(3). doi: 10.1002/mnfr.201600527. Epub 2016 Dec 5.