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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 Studienärzt*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)

SPRING: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating the Safety and Efficacy of CM-101 in Subjects with Primary Sclerosing 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 (offen)

BI1366-0021: Randomised, double-blind, placebo-controlled and parallel group trial to investigate the effects of two doses (up-titration to a fixed dose regimen) of oral BI 685509 on portal hypertension after 24 weeks treatment in patients with clinically significant portal hypertension (CSPH) in compensated cirrhosis (geplant)

Onkologische Studien

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

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

ESPAC-6: An open labelled phase III adjuvant trial of disease-free survival in patients with resected pancreatic ductal adenocarcinoma randomized to allocation of oxaliplatin- or gemcitabine-based chemotherapy by standard clinical criteria or by a transcriptomic treatment specific stratification signature (geplant)

CABONEN: A phase II trial of Cabozantinib in patients with advanced, low proliferative NEN G3 (offen)

CAMURUS:  A randomized, multi-center, open-label, active-controlled Phase 3 trial to assess the efficacy and safety of octreotide subcutaneous depot (CAM2029) versus octreotide LAR or lanreotide ATG in patients with gastroenteropancreatic neuroendocrine tumors (offen)

ABC-HCC: A Phase IIIb, randomized, multicenter, open-label trial of Atezolizumab plus Bevacizumab versus transarterial Chemoembolization (TACE) in intermediate-stage Hepatocellular Carcinoma with high disease burden (offen)

Outreach2: An Open Label, Randomised Phase 2 Study to Evaluate the Safety and Efficacy of MTL-CEBPA Administered in Combination with Sorafenib or Sorafenib Alone, in TKI Naive participants with Previously Treated Advanced Hepatocellular Carcinoma (HCC) and Hepatitis B or Hepatitis C Virus (geplant)

CaPture: Cabozantinib treatment in a phase II study for patients with hepatocellular carcinoma (HCC) refractory to PD-1 or PD-L1 inhibitors (geplant)

ADVANCE: A phase II single-arm, open-label study of Atezolizumab and Derazantinib for patients with adyanced intrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements (geplant)

CED Studien

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

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

RUN-UC: „Real World“ Wirksamkeit von Ustekinumab in der Induktions- und Erhaltungstherapie bei Colits ulcerosa (offen)

CSUC-01/21: A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate to Severe Active Left-Sided Ulcerative Colitis (offen)

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) (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)

GALAXI: A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease (offen)

M20-371: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD): AIM-CD (anti-TNF antibody-drug) (offen)

Ernährung

CEC-4/CEL: A phase IIb, double-blind, randomised, placebo-controlled trial to evaluate the efficacy and tolerability of ZED1227 in celiac disease subjects experiencing symptoms despite gluten-free diet (inhibitor of Transglutaminase 2) (offen)

Pekannuss: Open-label, randomized, multicenter, phase IV trial comparing parenteral nutrition using Eurotubes® vs. traditional 2/3-chamber bags in subjects with metastatic or locally advanced inoperable cancer requiring parenteral nutrition (offen)

Kontextspalte

Südwestdeutsches Studienzentrum
Dr. Ralf Jesenofsky

Dr. Ralf Jesenofsky


Organigramm des Studienzentrums