Inhalt

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)

BI 1404-0044: A randomised, double-blind, placebo-controlled, multicentre, Phase III trial evaluating long-term efficacy and safety of survodutide weekly injections in adult participants with non-cirrhotic non-alcoholic steatohepatitis/metabolic associated steatohepatitis (NASH/MASH) and (F2) - (F3) stage of liver fibrosis (geplant)

BI 1404-0064: A Phase III double-blind, randomised, placebo-controlled trial to evaluate liver-related clinical outcomes and safety of once weekly injected survodutide in participants with compensated non-alcoholic steatohepatitis/metabolic dysfunction associated steatohepatitis (NASH/MASH) cirrhosis (geplant)

Onkologische Studien

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

Liver-R: An Observational Multi-center Study to Evaluate Real-World Treatment Outcomes of Durvalumab-based Regimens in Hepatobiliary Cancers (offen)

idhira: Ivosidenib in locally advanced or metastatic cholangiocarcinoma with IDH1 R132 mutation after at least one prior systemic treatment - a prospective, multicenter, observational study in Germany (offen)

adIVO: A phase II trial of ivosidenib maintenance after SOC adjuvant chemotherapy in curative mIDH1 cholangiocarcinoma (geplant)

UNITEPANC: Using organoids to predict efficacy of adjuvant treatment to improve outcome in resectable pancreatic cancer - Interventional, prospective, multisite, proof-of-concept, single-arm trial

CED Studien

Clinnova-IBD: A prospective cohort study of patients with Inflammatory Bowel Disease: A Trans-Regional Digital Health Effort Unlocking the Potential of Artificial Intelligence and Data Science in Health Care (offen)

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

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

AMETRINE-1: A Phase III, multicenter, double-blind, placebo-controlled, treat-through study to assess the efficacy and safety of induction and maintenance therapy with RO7790121 in patients with moderately to severely active ulcerative colitis (offen)

Target-CD: A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects with Moderate to Severe Crohn's Disease (offen)

ORNATUS-1: A Phase II/III, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral controlled-ileocolonic-release nicotinamide (CICR-NAM) for induction and maintenance therapy in patients with mild to moderately active ulcerative colitis (offen)

SIBERITE-1: A Phase III, Multicenter, Double-Blind, Placebo Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy with RO7790121 in Patients with Moderately to Severely Active Crohn’s Disease GA45331 (offen)

TAK-279-CD-2001: A Phase 2b, Multicenter, Randomized, Double-Blind Induction, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects with Moderately to Severely Active Crohn’s Disease (offen)

VICTRIVA: A Randomized, Double-blind, Phase 3b Study to Evaluate the Short- and Long-term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenous Vedolizumab and Oral Placebo for Induction Followed by Intravenous Vedolizumab Monotherapy for Maintenance in the Treatment of Adults With Moderately to Severely Active Crohn’s Disease (offen)

Re-Introduce: Retreatment with subcutaneous Infliximab in patients with refractory Crohn’s disease - an observational study (offen)

Ernährung

CEC-013/CEL: A phase II, double-blind, randomised, placebo-controlled trial to evaluate the efficacy and tolerability of ZED1227 in celiac disease subjects experiencing symptoms despite gluten-free diet (offen)