Prof. Dr. med. Jan C. Simon

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About Prof. Dr. med. Jan C. Simon:

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SEEK ID: https://ldh.zks.uni-leipzig.de/people/8

Location: Germany

ORCID: https://orcid.org/0000-0003-0073-6061

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Leipzig University (Sponsor)

For 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.

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Web page: https://www.uniklinikum-leipzig.de/wissenschaft-forschung/forschungs-administration/klinische-studien

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BASALIT: Birch Associated Soy Allergy and Immuno-Therapy

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: Leipzig University (Sponsor)

Public web page: https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-011737-27/DE

End date: 18th Jul 2014

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Universitätsklinikum Leipzig, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

Country: Germany

City: Leipzig

Web page: https://www.uniklinikum-leipzig.de/einrichtungen/dermatologie

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A multicenter randomized-controlled trial of nucleos(t)ide analogue cessation in HBeAg-negative chronic hepatitis B.

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

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Abstract (Expand)

BACKGROUND & AIMS: Nucleos(t)ide analogues (NUCs) are the standard and mostly lifelong treatment for chronic HBeAg-negative hepatitis B, as functional cure (loss of HBsAg) is rarely achieved. … Discontinuation of NUC treatment may lead to functional cure; however, to date, the evidence for this has been based on small or non-randomized clinical trials. The STOP-NUC trial was designed with the aim of increasing the HBsAg loss rate using a NUC treatment interruption approach. METHODS: In this multicenter, randomized-controlled trial, 166 HBeAg-negative patients with chronic hepatitis B on continuous long-term NUC treatment, with HBV DNA <172 IU/ml (1,000 copies/ml) for >/=4 years, were randomized to either stop (Arm A) or continue NUC treatment (Arm B) for a 96-week observation period. In total, 158 patients were available for final analysis, 79 per arm. The primary endpoint was sustained HBsAg loss up to week 96. RESULTS: Our study met its primary objective by demonstrating HBsAg loss in eight patients (10.1%, 95% CI 4.8%-19.5%) in Arm A and in no patient in Arm B (p = 0.006). Among patients with baseline HBsAg levels <1,000 IU/ml, seven (28%) achieved HBsAg loss. In Arm A, re-therapy was initiated in 11 (13.9%) patients, whereas 32 (40.5%) patients achieved sustained remission. A decrease of HBsAg >1 log IU/ml was observed in 16 patients (20.3%) in Arm A and in one patient (1.3%) in Arm B. No serious adverse events related to treatment cessation occurred. CONCLUSIONS: Cessation of NUC treatment was associated with a significantly higher rate of HBsAg loss than continued NUC treatment, which was largely restricted to patients with end of treatment HBsAg levels <1,000 IU/ml. IMPACT AND IMPLICATIONS: As HBeAg-negative patients with chronic hepatitis B on nucleos(t)ide analogues (NUCs) rarely achieve functional cure, treatment is almost always lifelong. The STOP-NUC trial was conducted to investigate whether discontinuing long-term NUC treatment can increase the cure rate. We found that some patients achieved functional cure after stopping NUCs, which was especially pronounced in patients with HBsAg levels <1,000 at the end of NUC treatment, and that many did not need to resume therapy. The results of the Stop-NUC trial provide evidence for the concept of stopping NUC treatment as a therapeutic option that can induce functional cure.

Authors: F. van Bommel, K. Stein, R. Heyne, J. Petersen, P. Buggisch, C. Berg, S. Zeuzem, A. Stallmach, M. Sprinzl, E. Schott, A. Pathil-Warth, U. von Arnim, V. Keitel, J. Lohmeyer, K. G. Simon, C. Trautwein, A. Trein, D. Huppe, M. Cornberg, F. Lammert, P. Ingiliz, R. Zachoval, H. Hinrichsen, A. Zipprich, H. Klinker, J. Schulze Zur Wiesch, A. Schmiedeknecht, O. Brosteanu, T. Berg

Date Published: 18th Apr 2023

Publication Type: Journal

PubMed ID: 37062574

Citation: J Hepatol. 2023 May;78(5):926-936. doi: 10.1016/j.jhep.2022.12.018. Epub 2023 Mar 28.

Created: 22nd Aug 2023 at 14:31

Peptide epitopes as biomarkers of soya sensitization in rBet v 1 immunotherapy of birch-related soya allergy.

BASALIT: Birch Associated Soy Allergy and Immuno-Therapy

Abstract (Expand)

BACKGROUND: There are no diagnostic and/or prognostic markers of the treatment outcome in patients receiving allergen immunotherapy (AIT). Although numerous allergen epitopes are known, their value in …

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.

Created: 21st Oct 2024 at 11:55

Individualized positive end-expiratory pressure in obese patients during general anaesthesia: a randomized controlled clinical trial using electrical impedance tomography.

ADIPO-Vent: Optimierung der perioperativen maschinellen Ventilation bei adipösen und normalgewichtigen Patienten durch PEEP-Titration anhand der Elektrischen Impedanz-Tomografie

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BACKGROUND: General anaesthesia leads to atelectasis, reduced end-expiratory lung volume (EELV), and diminished arterial oxygenation in obese patients. We hypothesized that a combination of a recruitment …

Authors: C. Nestler, P. Simon, D. Petroff, S. Hammermuller, D. Kamrath, S. Wolf, A. Dietrich, L. M. Camilo, A. Beda, A. R. Carvalho, A. Giannella-Neto, A. W. Reske, H. Wrigge

Date Published: 1st Dec 2017

Publication Type: Journal

PubMed ID: 29045567

Citation: Br J Anaesth. 2017 Dec 1;119(6):1194-1205. doi: 10.1093/bja/aex192.

Created: 25th Jan 2024 at 07:45

BASALIT trial: double-blind placebo-controlled allergen immunotherapy with rBet v 1-FV in birch-related soya allergy.

BASALIT: Birch Associated Soy Allergy and Immuno-Therapy

Abstract (Expand)

BACKGROUND: Conflicting results exist on the effect of allergen immunotherapy (AIT) on pollen-related food allergy. We aimed to investigate the efficacy of one-year AIT with the folding variant (FV) …

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.

Created: 3rd Apr 2023 at 15:17

The BASALIT multicenter trial: Gly m 4 quantification for consistency control of challenge meal batches and toward Gly m 4 threshold data.

BASALIT: Birch Associated Soy Allergy and Immuno-Therapy

Abstract (Expand)

SCOPE: The BASALIT clinical trial (EudraCT 2009-011737-27) investigated efficacy of birch allergen immunotherapy on lowest observed adverse effect levels after soy food challenge in patients with …

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.

Created: 21st Oct 2024 at 11:54