Philipps-University Marburg

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Gerrit zur Hausen

Trial Projects:

Phosphodiesterase-5 inhibition in patients with heart failure with preserved ejection fraction and combined post- and pre-capillary pulmonary hypertension (PASSION)
Lymphadenectomy in Ovarian Neoplasms (LION)
Efficacy and safety of adjuvant immunoadsorption in pemphigus vulgaris and pemphigus foliaceus (IA-pem)
A randomized multicenter study to compare the efficacy of additional tumor debulking surgery versus chemotherapy alone for recurrent platinum-sensitive ovarian cancer
Efficacy and Safety of Pegylated-Proline-Interferon Alpha 2b (AOP2014) in Maintaining Deep Molecular Remissions in Patients with Chronic Myeloid Leukemia (CML) who Discontinue ABL-Kinase Inhibitor Therapy
A randomized, placebo-controlled, double-blind, multi-centre trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson's disease in Germany and the USA

Institutions: Philipps-University Marburg, Coordinating Center for Clinical Trials

https://orcid.org/0009-0009-8967-7299

Showing 5 out of a possible 6 Trial Projects Advanced Trial Projects list for this Sponsor with search and filtering

A randomized, placebo-controlled, double-blind, multi-centre trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson's disease in Germany and the USA

Transatlantic, multi-center, placebo-controlled, randomized, double-blind clinical trial to demonstrate that transdermal nicotine treatment retards parkinson's disease progression as measured by change in total (part I, II, III) UPDRS score between baseline and after 52 weeks of study treatment plus two more months wash out (60 weeks).

Sponsor: Philipps-University Marburg

Public web page: Not specified

Start date: 17th Oct 2012

End date: 15th Sep 2016

Efficacy and Safety of Pegylated-Proline-Interferon Alpha 2b (AOP2014) in Maintaining Deep Molecular Remissions in Patients with Chronic Myeloid Leukemia (CML) who Discontinue ABL-Kinase Inhibitor Therapy

Clinical trial to o evaluate the efficacy of AOP2014 in a randomized phase III, multicenter setting with post-study follow-up

Sponsor: Philipps-University Marburg

Public web page: Not specified

A randomized multicenter study to compare the efficacy of additional tumor debulking surgery versus chemotherapy alone for recurrent platinum-sensitive ovarian cancer

Clinical study to compare overall survival (OS) in patients with platinumsensitive recurrent ovarian cancer with a positive AGO-score randomized to tumor debulking surgery followed by chemotherapy of physician’s choice versus chemotherapy of physician’s choice alone

Sponsor: Philipps-University Marburg

Public web page: Not specified

Start date: 14th Jul 2010

End date: 17th Jan 2020

Efficacy and safety of adjuvant immunoadsorption in pemphigus vulgaris and pemphigus foliaceus (IA-pem)

Aim of the study is to investigate if adjuvant immunoadsorption is superior to standard immunosuppressive treatment in inducing clinical remission in pemphigus.

Sponsor: Philipps-University Marburg

Public web page: Not specified

Start date: 7th Mar 2011

End date: 9th Mar 2015

Lymphadenectomy in Ovarian Neoplasms (LION)

Clinical study to assess the efficacy of systematic pelvic and para-aortic lymphadenectomy in patients with advanced ovarian cancer and intra-abdominal complete debulking.

Sponsor: Philipps-University Marburg

Public web page: Not specified

Start date: 12th Dec 2008

End date: 31st Mar 2018

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Philipps-University Marburg, Coordinating Center for Clinical Trials

Country: Germany

City: Marburg

Web page: https://www.uni-marburg.de/de/fb20/bereiche/kks

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Tadalafil for Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension in Patients With Heart Failure and Preserved Ejection Fraction: A Randomized Controlled Phase 3 Study.

Phosphodiesterase-5 inhibition in patients with heart failure with preserved ejection fraction and combined post- and pre-capillary pulmonary hypertension (PASSION)

Abstract (Expand)

BACKGROUND: We assessed the efficacy and safety of tadalafil, a phosphodiesterase type 5 inhibitor, in patients with heart failure with preserved ejection fraction and combined postcapillary and …

Authors: M. M. Hoeper, B. Oerke, M. Wissmuller, H. Leuchte, C. Opitz, M. Halank, H. J. Seyfarth, S. Baldus, J. Bauersachs, M. Bohm, H. A. Ghofrani, S. Konstantinides, K. M. Olsson, R. Wachter, C. S. P. Lam, B. Aminossadati, S. Rosenkranz

Date Published: 20th Aug 2024

Publication Type: Journal

PubMed ID: 38939948

Citation: Circulation. 2024 Aug 20;150(8):600-610. doi: 10.1161/CIRCULATIONAHA.124.069340. Epub 2024 Jun 28.

Created: 19th Nov 2024 at 11:51

Efficacy and safety of adjuvant immunoadsorption in pemphigus vulgaris and pemphigus foliaceus (IA-Pem Study): a multicentre randomized controlled trial.

Efficacy and safety of adjuvant immunoadsorption in pemphigus vulgaris and pemphigus foliaceus (IA-pem)

Abstract (Expand)

BACKGROUND: Pemphigus vulgaris (PV) and pemphigus foliaceus (PF) are potentially life-threatening autoimmune blistering diseases. Treatment is based on long-term immunosuppression with high doses of … glucocorticosteroids in combination with potentially corticosteroid-sparing agents and/or rituximab. Immunoadsorption (IA) has emerged as a fast-acting adjuvant treatment option. OBJECTIVES: To assess the clinical efficacy of IA in addition to best medical treatment (BMT). METHODS: We conducted a multicentre (26 centres from Germany and Austria) randomized controlled trial in 72 patients with newly diagnosed, relapsed or chronic active PV or PF (34 female patients and 38 male patients, aged 42-72 years) comparing BMT (prednisolone 1.0 mg kg-1 per day plus azathioprine or mycophenolate) with adjuvant IA (BMT + IA). Central 1 : 1 randomization was done at the coordinating centre for clinical trials (KKS Marburg). The primary endpoint was analysed using Kaplan-Meier and Cox regression methods. RESULTS: The study was ended prematurely owing to safety concerns after random allocation of 72 patients to BMT + IA (n = 34) or BMT (n = 38). The primary endpoint, time to complete remission on therapy, was not significantly different for the two groups [hazard ratio (HR) 1.35, 95% confidence interval (CI) 0.68-2.69; P = 0.39]. The cumulative dose of prednisolone was significantly lower in the BMT + IA group compared with BMT alone (difference -1214, 95% CI -2225 to -70; P = 0.03). In a post hoc analysis, patients with more extensive PV/PF showed a tendency towards a shorter time to remission in the BMT + IA group compared with the BMT group (HR 1.87, P = 0.17 in patients with baseline Pemphigus Disease Area Index >/= 15). While more adverse events were observed in patients in the BMT group (29 vs. 25), severe adverse events were more frequent in patients in the BMT + IA group (17 events in 10 patients vs. 11 events in 8 patients). CONCLUSIONS: In this study, adjuvant IA did not demonstrate a shorter time to clinical remission, but a corticosteroid-sparing effect was observed. In patients with extensive PV/PF, post hoc analysis suggests that adjuvant IA may lead to earlier remission, but potential adverse events must be carefully weighed against the expected benefits.

Authors: N. van Beek, R. Eming, A. Reuss, D. Zillikens, M. Sardy, C. Gunther, D. Kiritsi, S. Benoit, S. Beissert, R. Glaser, H. Gollnick, O. N. Horvath, C. Pfeiffer, M. Rocken, F. Schauer, S. Schreml, K. Steinbrink, A. Zink, C. Schade-Brittinger, M. Hertl, E. Schmidt

Date Published: 17th Apr 2024

Publication Type: Journal

PubMed ID: 38133541

Citation: Br J Dermatol. 2024 Apr 17;190(5):657-667. doi: 10.1093/bjd/ljad489.

Created: 25th Nov 2024 at 12:06

Transdermal Nicotine Treatment and Progression of Early Parkinson's Disease.

A randomized, placebo-controlled, double-blind, multi-centre trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson's disease in Germany and the USA

Abstract (Expand)

BACKGROUND: Epidemiologic studies show that smokers have a lower incidence of Parkinson's disease. Nicotine has been hypothesized to slow progression in early Parkinson's disease. METHODS: In …

Authors: W. H. Oertel, H. H. Muller, M. M. Unger, C. Schade-Brittinger, K. Balthasar, K. Articus, M. Brinkman, C. S. Venuto, F. Tracik, J. Eberling, K. M. Eggert, C. Kamp, K. Kieburtz, J. T. Boyd

Date Published: 8th Feb 2024

Publication Type: Journal

PubMed ID: 38320207

Citation: NEJM Evid. 2023 Sep;2(9):EVIDoa2200311. doi: 10.1056/EVIDoa2200311. Epub 2023 Aug 22.

Created: 6th Dec 2024 at 13:22

Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer.

A randomized multicenter study to compare the efficacy of additional tumor debulking surgery versus chemotherapy alone for recurrent platinum-sensitive ovarian cancer

Abstract (Expand)

BACKGROUND: Treatment for patients with recurrent ovarian cancer has been mainly based on systemic therapy. The role of secondary cytoreductive surgery is unclear. METHODS: We randomly assigned patients …

Authors: P. Harter, J. Sehouli, I. Vergote, G. Ferron, A. Reuss, W. Meier, S. Greggi, B. J. Mosgaard, F. Selle, F. Guyon, C. Pomel, F. Lecuru, R. Zang, E. Avall-Lundqvist, J. W. Kim, J. Ponce, F. Raspagliesi, G. Kristensen, J. M. Classe, P. Hillemanns, P. Jensen, A. Hasenburg, S. Ghaem-Maghami, M. R. Mirza, B. Lund, A. Reinthaller, A. Santaballa, A. Olaitan, F. Hilpert, A. du Bois

Date Published: 2nd Dec 2021

Publication Type: Journal

PubMed ID: 34874631

Citation: N Engl J Med. 2021 Dec 2;385(23):2123-2131. doi: 10.1056/NEJMoa2103294.

Created: 25th Nov 2024 at 13:23

A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms.

Lymphadenectomy in Ovarian Neoplasms (LION)

Abstract (Expand)

BACKGROUND: Systematic pelvic and paraaortic lymphadenectomy has been widely used in the surgical treatment of patients with advanced ovarian cancer, although supporting evidence from randomized clinical … trials has been limited. METHODS: We intraoperatively randomly assigned patients with newly diagnosed advanced ovarian cancer (International Federation of Gynecology and Obstetrics stage IIB through IV) who had undergone macroscopically complete resection and had normal lymph nodes both before and during surgery to either undergo or not undergo lymphadenectomy. All centers had to qualify with regard to surgical skills before participation in the trial. The primary end point was overall survival. RESULTS: A total of 647 patients underwent randomization from December 2008 through January 2012, were assigned to undergo lymphadenectomy (323 patients) or not undergo lymphadenectomy (324), and were included in the analysis. Among patients who underwent lymphadenectomy, the median number of removed nodes was 57 (35 pelvic and 22 paraaortic nodes). The median overall survival was 69.2 months in the no-lymphadenectomy group and 65.5 months in the lymphadenectomy group (hazard ratio for death in the lymphadenectomy group, 1.06; 95% confidence interval [CI], 0.83 to 1.34; P = 0.65), and median progression-free survival was 25.5 months in both groups (hazard ratio for progression or death in the lymphadenectomy group, 1.11; 95% CI, 0.92 to 1.34; P = 0.29). Serious postoperative complications occurred more frequently in the lymphadenectomy group (e.g., incidence of repeat laparotomy, 12.4% vs. 6.5% [P = 0.01]; mortality within 60 days after surgery, 3.1% vs. 0.9% [P = 0.049]). CONCLUSIONS: Systematic pelvic and paraaortic lymphadenectomy in patients with advanced ovarian cancer who had undergone intraabdominal macroscopically complete resection and had normal lymph nodes both before and during surgery was not associated with longer overall or progression-free survival than no lymphadenectomy and was associated with a higher incidence of postoperative complications. (Funded by Deutsche Forschungsgemeinschaft and the Austrian Science Fund; LION ClinicalTrials.gov number, NCT00712218.).

Authors: P. Harter, J. Sehouli, D. Lorusso, A. Reuss, I. Vergote, C. Marth, J. W. Kim, F. Raspagliesi, B. Lampe, G. Aletti, W. Meier, D. Cibula, A. Mustea, S. Mahner, I. B. Runnebaum, B. Schmalfeldt, A. Burges, R. Kimmig, G. Scambia, S. Greggi, F. Hilpert, A. Hasenburg, P. Hillemanns, G. Giorda, I. von Leffern, C. Schade-Brittinger, U. Wagner, A. du Bois

Date Published: 28th Feb 2019

Publication Type: Journal

PubMed ID: 30811909

Citation: N Engl J Med. 2019 Feb 28;380(9):822-832. doi: 10.1056/NEJMoa1808424.

Created: 25th Nov 2024 at 11:43

Showing 5 out of a possible 6 Documents Advanced Documents list for this Sponsor with search and filtering

Study Protocol - NIC-PD

A randomized, placebo-controlled, double-blind, multi-centre trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson's disease in Germany and the USA

No description specified

Creator: Gerrit zur Hausen

Submitter: Gerrit zur Hausen

Created: 6th Dec 2024 at 13:20

Study Protocol - Efficacy and Safety of Pegylated-Proline-Interferon Alpha 2b (Aop2014) in Maintaining Deep Molecular Remissions in Patients with Chronic Myeloid Leukemia (CML) who Discontinue ABL-Kinase Inhibitor Therapy

Efficacy and Safety of Pegylated-Proline-Interferon Alpha 2b (AOP2014) in Maintaining Deep Molecular Remissions in Patients with Chronic Myeloid Leukemia (CML) who Discontinue ABL-Kinase Inhibitor Therapy

No description specified

Creator: Gerrit zur Hausen

Submitter: Gerrit zur Hausen

Created: 27th Nov 2024 at 12:44

Study Protocol - A randomized multicenter study to compare the efficacy of additional tumor debulking surgery versus chemotherapy alone for recurrent platinum-sensitive ovarian cancer

A randomized multicenter study to compare the efficacy of additional tumor debulking surgery versus chemotherapy alone for recurrent platinum-sensitive ovarian cancer

No description specified

Creator: Gerrit zur Hausen

Submitter: Gerrit zur Hausen

Created: 25th Nov 2024 at 12:55

Study Protocol - Efficacy and safety of adjuvant immunoadsorption in pemphigus vulgaris and pemphigus foliaceus

Efficacy and safety of adjuvant immunoadsorption in pemphigus vulgaris and pemphigus foliaceus (IA-pem)

No description specified

Creator: Gerrit zur Hausen

Submitter: Gerrit zur Hausen

Created: 25th Nov 2024 at 12:05

LYMPHADENECTOMY IN OVARIAN NEOPLASMS

Lymphadenectomy in Ovarian Neoplasms (LION)

No description specified

Creator: Gerrit zur Hausen

Submitter: Gerrit zur Hausen

Created: 25th Nov 2024 at 11:41

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