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)

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-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)

FORTUNA: A Randomised, Double-blind, Placebo-controlled, Multi-centre Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) with Fibrosis Who Are Carriers of the PNPLA3 rs738409 148M Risk Allele (geplant)

Onkologische Studien

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 (offen)

CARP: Cholangiocarcinoma treatment with radiofrequency ablation or photodynamic therapy (offen)

SIERRA: A Phase IIIb Single Arm, Open-label, Multicentre Study of Durvalumab and Tremelimumab as First Line Treatment in Participants with Advanced Hepatocellular Carcinoma (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)

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)

DUET-UC: A Phase 2b Randomized, Double-blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis (geplant)

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)

DUET-CD: A Phase 2b Randomized, Double-blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Crohn’s Disease (geplant)

PROGRESS: A Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Guselkumab for the Treatment of Participants with Crohn’s Disease After Surgical Resection (geplant)

FUZION: A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants with Fistulizing, Perianal Crohn’s Disease (geplant)

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)

Pankreas

PESPA: A prospective evaluation of scoring systems for chronic pancreatitis (offen)