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Südwestdeutsches Studienzentrum

Das Studienzentrum der II. Medizinischen Klinik führt klinische Studien der Phase I bis IV durch. Neben zahlreichen Investigator-initiated Trials (IIT) werden klinische Studien aller Phasen in den Bereichen der Gastroenterologie (CED), der gastroenterologischen Onkologie, der Hepatologie, der Infektiologie u.a. durchgeführt. Die Studienärzte/innen und Studienassistentinnen bilden sich regelmäßig fort und sind hinsichtlich der klinischen Studiendurchführung ausgewiesene Experten. Die Klinik ist integraler Bestandteil verschiedener Studiennetzwerke und kooperiert mit den Klinischen Studienzentren in Heidelberg und Freiburg. Innovative Studien bilden ein wesentliches Element der universitären Maximalversorgung.

Leberstudien

DHC-R: Deutsches Hepatitis C Register (offen)

RDG-1/ PBC: Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of Rhudex granules with placebo in the treatment of primary biliary cholangitis (offen)

Vir-3434:  A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-3434 (offen)

Vir-2218:  A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of VIR-2218 + VIR-3434 in Subjects with Chronic Hepatitis B Virus Infection (geplant)

1404-0043: Multicenter, double-blind, parallel-group, randomised, 48 weeks, dose-ranging, placebo-controlled phase II trial to evaluate efficacy, safety and tolerability of multiple subcutaneous (s.c.) doses of BI 456906 in patients with non-alcoholic steatohepatitis (NASH) and fibrosis (geplant)

Onkologische Studien

ACTICCA-1: Adjuvant chemotherapy with gemcitabine and cisplatin compared to observation after curative intent resection of cholangiocarcinoma (offen)

CONKO-007 Randomisierte Phase III-Studie zum Stellenwerk einer Radiochemotherapie nach Induktionschemotherapie beim lokal begrenzten, inoperablen Pankreaskarzinom: Chemotherapie gefolgt von Radiochemotherapie im Vergleich zur alleinigen Chemotherapie (Rekrutierung beendet)

PROMISE: Aus Patienten stammende Organoide zur Modellierung der Tumorbiologie und Vorhersage von Therapieansprechen (offen)

NALIRICC (AIO-HEP-0116): A randomized phase II trial of nal-IRI and 5-Fluorouracil compared to 5-Fluorouracil inpatients with cholangio- and gallbladder carcinoma previously treated with gemcitabine or gemcitabine containing therapies (Rekrutierung beendet)

RAMONA A multicenteR open-label phase II-trial to evaluate NivoluMab and Ipilimumab fOr 2nd line therapy in elderly patients with advanced esophageal squamous cell cancer (Rekrutierung beendet)

EpiReal: Epidemiologische Studie für geriatrische Onkologie und Biologie in der Metropolregion. Biomaterialsammlung und prospektive Datenerfassung zu Diagnostik, Therapie, sozioökonomischem Umfeld und Krankheitsverlauf von an Krebs erkrankten Patienten>=75 Jahren (offen)

Predict: Second-line therapy with Nal-IRI after failure of gemcitabine/nab-paclitaxel in advanced pancreatic cancer - predictive role of 1st-line therapy (Rekrutierung beendet)

IMMUTACE: A Phase II single-arm, open-label study of transarterial chemoembolization (TACE) in combination with nivolumab performed for intermediate stage hepatocellular carcinoma (HCC) (Rekrutierung beendet)

IMMUCHEC: A randomized phase II trial of durvalumab and tremelIMUMab with gemcitabine or gemcitabine and cisplatin compared to gemcitabine and cisplatin in treatment-naïve patients with Cholangio- and gallbladder Carcinoma (IMUCHEC) (Rekrutierung beendet)

COLOSSUS: Identification of new patient stratification tools in microsatellite stable (MSS) RAS mutant (mt) metastatic Colorectal Cancer (mCRC) – COLOSSUS / CTRIAL-IE 17-26 (offen)

RELEASE, PCIA203-18: A Multi-Centre, Randomised, Open-Label, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of Fimaporfin-Induced Photochemical Internalisation of Gemcitabine Complemented by Gemcitabine/Cisplatin Chemotherapy Versus Gemcitabine/Cisplatin Alone in Patients With Inoperable Cholangiocarcinoma (offen)

DIAL-1: A phase I/II multicenter, open-label Study of DKN-01 to investigate the anti-tumor activity and safety of DKN-01 in patients with Hepatocellular Carcinoma and Wnt signaling Alterations (offen)

BMS CA209-9DW: A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination with Ipilimumab
Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants with Advanced Hepatocellular Carcinoma (offen)

CED Studien

GA29145 (Juniper): An open-label extension and safety monitoring study of patients with moderately to severely active Crohn´s disease previously enrolled in the Etrolizumab phase III protocol GA29144 (Rekrutierung beendet)

GA28951 (Cottonwood): An open-label extension and safety monitoring study of moderate to severe Ulcerative Colitis patients previously entrolled in Etrolizumab phase III studies (Rekrutierung beendet)

Biocolitis/CapColitis: Biologika-Register bei Patienten mit Colitis Ulcerosa / Video-Kapselendoskopie (offen)

I-CARE: IBD cancer and serious infections in Europe (offen)

MLN-0002_401: Entyvio (vedolizumab) long-term safety study: an international observational prospective cohort study comparing vedolizumab to other biologic agents in patients with ulcerative colitis or Crohn’s Disease (offen)

M14-234: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis (Rekrutierung beendet)

M14-533: A Phase 3 Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis (UC) (Rekrutierung beendet)

Yellowstone GA39925: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC) (Rekrutierung beendet)

M16-066: A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 (offen)

M16-067: A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy (offen)

M16-000: A Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-98 (Rekrutierung beendet)

M15-991: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment (Rekrutierung beendet)

M16-006: A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease (Rekrutierung beendet)

Power: A phase 3b, randomized, double blind, multicenter study to evaluate the safety and efficacy of intravenous Re-induction therapy with Ustekinumab in subjects with moderately to severely active crohn´s disease (offen)

M14-430: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Crohn's Disease who Completed the Studies M14-431 or M14-433 (Rekrutierung beendet)

M14-431: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy (Rekrutierung beendet)

M14-433: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Conventional Therapies but Have Not Failed Biologic Therapy (Rekrutierung beendet)

AMUC: A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects with Mild to Moderate Ulcerative Colitis (Sphingosine 1 Receptor-1 Antagonist) (geplant)

TAK-018: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence (offen)

IM011023: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Crohn's Disease (offen)

M20-259: A phase 3, multicenter, Randomized, Open Label, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects with Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy (Risankizumab – IL23 Antikörper) (offen)

Übrige Studien

HIV-1 Serokonverterstudie: Eine Studie zur Ermittlung der Einflussgrössen auf den Verlauf der HIV-Erkrankung, der Verbreitung von HIV-Subtypen sowie der Übertragung resistenter Viren.
(offen)

BarrettNet:  Identifizierung und Analyse von Biomarkern für die Entstehung des Adenokarzinoms aus Barrett-Ösophagus mittels PAXgene® Gewebefixierung.
(offen)

Kontextspalte

Südwestdeutsches Studienzentrum
Dr. Ralf Jesenofsky

Dr. Ralf Jesenofsky


Organigramm des Studienzentrums