Digestive Centre

Clinical studies

Patients who wish to do so can participate in a clinical trial. Here is a list of the current studies:

Digestive oncology (more info with Dr E. Monsaert and Dr. E. Vanderstraeten)

  • TRIPP-FFX (Oncosil): An open-label, multicentre, randomised trial on targeted intratumor placement of phosphorus-32 (OncoSil™) as a supplement to FOLFIRINOX chemotherapy versus only using FOLFIRINOX chemotherapy in patients who have inoperative, locally-advanced adenocarcinoma of the pancreas.
  • SORENTO / HS-19-657 (Camurus): A randomised, multi-centre, open-label, actively controlled phase-III study to evaluate the safety and effectiveness of the octreotide subcutaneous depot (CAM2029) versus octreotide LAR or lanreotide ATG in patients who have neuroendocrine gastroenteropancreatic tumours.
  • NALPAC (BGDO): A non-comparative randomised phase-II study evaluating the efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX in patients with metastatic ductal pancreatic adenoma carcinoma progressive after gemcitabine-abraxana or gemcitabine monotherapy.
  • PREFER (Amsterdam University): Study on the safety of endoscopic follow-up of early oesophageal cancer.
  • Folicolor trial (UZA): Follow-up of treatment response using blood samples in metastatic colorectal cancer patients.
  • PAPHYRA (UZB Erasmus Hospital): Evaluation of the physician-patient relationship after consultation for the implementation of a new systematic treatment for advanced hepatocellular carcinoma: need for information, knowledge of the prognosis and expectations for the treatment in terms of efficacy and side effects.

Crohn's Disease and/or Colitis Ulcerosa (more information with Dr D. Baert, Dr. N. Deprez and Prof Dr P. Dewint)

  • 1425-0003 (Boehringer Ingelheim): A randomised, double-blind, placebo-controlled phase-IIa study to evaluate the safety, efficacy, pharmacokinetics and pharmodynamics of BI 706321 as orally administered for twelve weeks in patients with Crohn's disease who are receiving induction treatment with ustekinumab.
  • CULTIVATE (Arena): A randomised, double-blind, placebo-controlled, multi-centre phase III study to assess whether Etrolizumab is a safe and efficacious treatment for participants with moderately to severely active Crohn's Disease.
  • SOPRANO CD (Leuven University Hospital) Prevention of postoperative endoscopic disease recurrence in Crohn's disease: a multicentre study comparing the systematic initiation of biologic therapy immediately after surgical resection with the more targeted initiation of biologic therapy in patients with endoscopic lesions six months after surgery.
  • ABTECT (Abivax): A multi-centre randomised, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of ABX464 once daily as an induction/maintenance treatment in subjects with moderately to severely active ulcerative colitis.
  • GALOCEAN (Galapagos): A prospective, non-interventional multi-country study of the efficacy of filgotinib in adult patients with moderately to severely active ulcerative colitis.

Endoscopic treatments (more information with Prof. Dr P. Dewint and Dr. S. Van Langendonck)

  • PURASTAT duodenum (Leuven University Hospital): Study to evaluate the effectiveness of PuraStat® in preventing delayed bleeding after endoscopic mucosal resection (EMR) of non-ampullary duodenal lesions (NADLs).
  • ENDONASH (ULB) Multicentre study to evaluate an endoluminal suture system (Endomina®) as support for treatment of non-alcoholic steatohepatitis.

Celiac disease (more info at Dr D. Baert)

  • TAK-062-2001 (Takeda): A randomised, double-blind, placebo-controlled phase-II dose range study evaluating the efficacy and safety of TAK-062 for the treatment of active celiac disease in subjects attempting to follow a gluten-free diet.

Scientific research is indispensable for the advancement of science. By participating in clinical studies, we are able to expand current treatment options and provided patients with access to the very latest treatments.

Non-alcoholic steatohepatitis (NASH) (more information with Prof Dr C. Van Steenkiste and Dr. T. De Somer)

  • ESSENCE/NN9931-4553 (Novo Nordisk): The effect of semaglutide on test subjects with non-cirrhotic, non-alcoholic steatohepatitis.
  • NATiV3 / 337HNAS20011 (Inventiva Pharma): A randomised, double-blind, placebo-controlled, phase-3 study in multiple centres to evaluate the long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic, non-alcoholic steatohepatitis (NASH) and liver fibrosis in fibrosis stage 2 (F2)/fibrosis stage 3 (F3).
  • MAESTRO-NASH (Madrigal): A randomised, double-blind, placebo-controlled phase 3 study to assess the effect of resmetirom on liver-related outcomes in patients with well-compensated (Child-Pugh A) non-alcoholic steatohepatitis (NASH) cirrhosis
  • RED-C (Salix): A randomised, double-blind, placebo-controlled, multicentre study to assess the efficacy and safety of rifaximin soluble solid dispersion tablets in the delay of encephalopathy decompensation in cirrhosis.

Alcoholic hepatitis (more information with Prof. Dr C. Van Steenkiste and Dr. T. De Somer)

  • Cortisave: Evaluation of the efficacy of corticosteroids in the treatment of alcoholic hepatitis in spontaneous improvement.

Clostridium difficile infection (more information from Prof Dr C. Van Steenkiste and Dr. T. De Somer)

Participation in these studies is on a voluntary basis and written consent is required. You are free to stop them whenever you wish, without this impacting your ongoing treatment or relationship with your physician.