{"id":1085085,"date":"2024-05-28T16:05:19","date_gmt":"2024-05-28T16:05:19","guid":{"rendered":"https:\/\/gi.med.uoc.gr\/?page_id=1085085"},"modified":"2024-12-04T12:38:50","modified_gmt":"2024-12-04T12:38:50","slug":"clinical-trials","status":"publish","type":"page","link":"https:\/\/gi.med.uoc.gr\/en\/clinical-research\/clinical-trials\/","title":{"rendered":"Clinical trials"},"content":{"rendered":"

[et_pb_section fb_built=”1″ fullwidth=”on” admin_label=”Hero” _builder_version=”4.16″ _module_preset=”default” use_background_color_gradient=”on” background_color_gradient_direction=”90deg” background_color_gradient_stops=”#0f3875 0%|#2054a5 100%” background_color_gradient_start=”#0f3875″ background_color_gradient_end=”#2054a5″ custom_margin=”||||false|false” custom_margin_tablet=”0px||||false|false” custom_margin_phone=”0px||||false|false” custom_margin_last_edited=”on|phone” custom_padding=”||||false|false” locked=”off” global_colors_info=”{}”][et_pb_fullwidth_header title=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IiIsImFmdGVyIjoiIn19@” button_one_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjIzIn19@” _builder_version=”4.26.1″ _dynamic_attributes=”button_one_url,title” _module_preset=”default” title_font=”Nunito||||||||” title_font_size=”50px” title_line_height=”1.3em” content_font=”Open Sans||||||||” content_font_size=”20px” content_line_height=”1.6em” background_enable_color=”off” background_color_gradient_direction=”90deg” background_color_gradient_start=”#0f3875″ background_color_gradient_end=”#2054a5″ background_enable_image=”off” custom_button_one=”on” button_one_text_size=”20px” button_one_bg_color=”#2054A5″ button_one_border_width=”0px” button_one_border_color=”#FFFFFF” button_one_border_radius=”0px” button_one_letter_spacing=”2.5px” button_one_font=”Nunito||||||||” button_one_on_hover=”off” button_one_custom_padding=”|44px|||false|false” custom_padding=”60px||60px||false|false” title_font_size_tablet=”30px” title_font_size_phone=”30px” title_font_size_last_edited=”on|tablet” content_font_size_tablet=”16px” content_font_size_phone=”16px” content_font_size_last_edited=”on|tablet” background_last_edited=”on|phone” use_background_color_gradient_phone=”on” background_color_gradient_stops_phone=”#0f3875 0%|#2054a5 100%” background_color_gradient_end_phone=”#2054a5″ global_colors_info=”{}” button_one_bg_color__hover_enabled=”on|hover” button_one_bg_color__hover=”#0F3875″ button_one_bg_enable_color__hover=”on” button_one_border_width__hover_enabled=”off|desktop”][\/et_pb_fullwidth_header][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.24.2″ _module_preset=”default” width=”100%” width_tablet=”” width_phone=”” width_last_edited=”on|tablet” module_alignment=”center” global_colors_info=”{}”][et_pb_row _builder_version=”4.24.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.24.2″ _dynamic_attributes=”content” _module_preset=”default” custom_margin=”||0px||false|false” global_colors_info=”{}”]@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IjxoMj4iLCJhZnRlciI6IjwvaDI+In19@[\/et_pb_text][et_pb_divider color=”#0F3875″ divider_weight=”3px” _builder_version=”4.24.2″ _module_preset=”default” width=”150px” custom_margin=”0px||10px||false|false” custom_padding=”0px||0px||false|false” locked=”off” global_colors_info=”{}”][\/et_pb_divider][et_pb_text _builder_version=”4.26.1″ _module_preset=”default” text_font_size=”16px” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n

 <\/p>\n

The Gastroenterology Department of Heraklion University Hospital is a referral center for complicated diseases of the digestive tract, such as Inflammatory Bowel Diseases (IBD) and liver diseases. Hence, it is attractive and often selected as a clinical trials center for phase II, III and IV studies on Crohn’s Disease, Ulcerative Colitis and liver diseases.<\/p>\n

Team<\/strong><\/p>\n

Prof. Ioannis Koutroubakis (Director)
Kalliopi Foteinogiannopoulou (Consultant)
Ioannis Drygiannakis (Consultant)
Marina Mavrogianni (Research Nurse)
Ioannis Athanasakis (Site Study Coordinator)<\/p>\n

Definition of a clinical trial<\/strong><\/p>\n

Scientific research that tests the safety and effectiveness of new drugs\/treatments<\/p>\n

Who designs a clinical trial?<\/strong><\/p>\n

Clinical Studies are designed by interdisciplinary teams abroad and in Greece and then approved by the Greek National Organization for Medicines and by the Ethics Committee of the Heraklion University Hospital.<\/p>\n

Kinds of clinical trials<\/strong><\/p>\n

    \n
  1. Observational, non-interventional: Patients receive approved drugs prescribed by the attending physician based on usual clinical practice without additional follow-up procedures.<\/li>\n
  2. Interventional in which the safety and effectiveness of new drugs are studied: Patients receive new\/under-study drugs free of charge and are closely followed up in the Gastroenterology Department, University Hospital of Heraklion.<\/li>\n<\/ol>\n

    Diseases clinical trials are available for<\/strong>
    Crohn’s Disease, ulcerative colitis, hepatitis B, primary biliary cholangitis, hepatocellular carcinoma<\/p>\n

    May I participate?<\/strong><\/p>\n

    All patients fitting the inclusion and exclusion criteria<\/strong> of a study may participate, after being informed, in detail and after signing a written informed consent form.<\/p>\n

    Can someone withdraw from a clinical trial?<\/strong>
    Participants can withdraw at any time without any further explanation due and without any negative impact on the health services they receive.<\/p>\n

    Reasons to participate<\/strong><\/p>\n

      \n
    1. Access to new treatments that are not currently commercially available<\/li>\n
    2. Healthcare by experts<\/li>\n
    3. Close monitoring<\/li>\n
    4. Free health workup<\/li>\n
    5. Volunteering to benefit humanity by advancing knowledge on novel effective treatments<\/li>\n<\/ol>\n

      https:\/\/www.clinicaltrials.gov is a resource for most past and current clinical trials worldwide.<\/p>\n

      Contact<\/strong><\/p>\n

      Ioannis Athanasakis: athanasakis.sc@gmail.com<\/a>, +302810392037<\/p>\n

      List of clinical trials<\/strong><\/p>\n

      M14-658 (pediatric ulcerative colitis – upadacitinib)
      ABX464-105 (ulcerative colitis – ABX464)
      CNTO1959CRD3005 Fuzion (Crohn’s disease – guselkumab)
      MK7240-001 (ulcerative colitis – MK-7240)
      GA44839 Moonglow (vixarelimab – ulcerative colitis)
      P22-921 Profundus (upadacitinib – ulcerative colitis)
      P23-899 Uplift (upadacitinib – Crohn’s disease)
      PASS TOFA (tofacitinib – ulcerative colitis)
      22453 Refine-IO (atezolizumab & bevacizumab – hepatocellular carcinoma)
      \u0391\u03a4\u0397\u0395\u039d\u0391 (\u03bb\u03b5\u03c5\u03ba\u03b1\u03c6\u03b1\u03af\u03c1\u03b5\u03c3\u03b7 – ulcerative colitis)
      M14-671 (upadacitinib – Crohn’s disease)
      M23-703 (lutikizumab – ulcerative colitis)
      MK7240-008 (tulisokibart – Crohn’s disease)
      M14-433 (upadacitinib – Crohn’s disease)
      M14-430 (upadacitinib – Crohn’s disease)
      M14-533 (upadacitinib – ulcerative colitis)
      M20-259 (risankizumab vs ustekinumab – Crohn’s disease)
      M20-371 (ABBV-154 – Crohn’s disease)
      M23-784 (risankizumab – Crohn’s disease)
      M14-234 (upadacitinib – ulcerative colitis)
      M14-675 (upadacitinib – ulcerative colitis)
      M15-991 (risankizumab – Crohn’s disease)
      M16-000 (risankizumab – Crohn’s disease)
      M16-006 (risankizumab – Crohn’s disease)
      M16-066 (risankizumab – ulcerative colitis)
      M16-067 (risankizumab – ulcerative colitis)
      ABX464-107 (ABX464 – ulcerative colitis)
      20170104 (efavaleukin alpha – ulcerative colitis)
      20210210 (efavaleukin alpha – ulcerative colitis)
      APD334-202EU (efavaleukin alpha – ulcerative colitis)
      BI 1297.4 (BI 695501 vs Humira – Crohn’s disease)
      BI 1368-0005 (spesolimab – ulcerative colitis)
      BI 1368-0017 (spesolimab – ulcerative colitis)
      GED-0301-CD-002 (mongersen – Crohn’s disease)
      GED-0301-CD-004 (mongersen – Crohn’s disease)
      RPC01-3101 (RPC1063 – ulcerative colitis)
      RPC01-3102 (RPC1063 – ulcerative colitis)
      RPC01-3202 (ozanimod – Crohn’s disease)
      RPC01-3203 (ozanimod – Crohn’s disease)
      RPC01-3204 (ozanimod – Crohn’s disease)
      CT-P13 3.7 (CT-P13 sc – ulcerative colitis)
      CT-P13 3.8 (CT-P13 sc – Crohn’s disease)
      CB8025_32048 (seladelpar – primary biliary cholangitis)
      GSN000350 TRANSFORM (setanaxib – primary biliary cholangitis)
      206882 B-Sure (GSK3228836 – hepatitis B)
      219288 B-Well-2 (bepirovirsen – hepatitis B)
      CNTO1959CRD3001 Galaxi (guselkumab – Crohn’s disease)
      GA28949 (etrolizumab vs adalimumab – ulcerative colitis)
      GA28950 (etrolizumab – ulcerative colitis)
      GA28951 (etrolizumab – ulcerative colitis)
      GA39925 (UTTR1147A – ulcerative colitis)
      GA40209 (UTTR1147A – Crohn’s disease)
      SHP647-304 AIDA (SHP647 – ulcerative colitis or Crohn’s disease)
      SHP647-306 CARMEN CD 306 (SHP647 – Crohn’s disease)
      SHP647-307 CARMEN CD 307 (SHP647 – Crohn’s disease)
      0157 Rhea (TD-1473 – ulcerative colitis)
      0164 (TD-1473 – ulcerative colitis)
      0173 Dione (TD-1473 – ulcerative colitis)
      11318 Modify (adalimumab – Crohn’s disease)
      H23-539 Podcast (ulcerative colitis or Crohn’s disease)
      MLN0002-401 (vedolizumab – ulcerative colitis or Crohn’s disease)
      VDZ-5036 EVOLVE (vedolizumab – ulcerative colitis or Crohn’s disease)
      Vedolizumab-4018 TROVE (vedolizumab – ulcerative colitis or Crohn’s disease)
      CNTO148UCO4001 OPAL (ulcerative colitis)
      CNTO1275CRD4015 Reassure (Crohn’s disease)
      2019EOMIFNEmp (ulcerative colitis or Crohn’s disease)
      D419CR00023 OPAL (hepatocellular carcinoma)<\/p>\n

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        The Gastroenterology Department of Heraklion University Hospital is a referral center for complicated diseases of the digestive tract, such as Inflammatory Bowel Diseases (IBD) and liver diseases. Hence, it is attractive and often selected as a clinical trials center for phase II, III and IV studies on Crohn’s Disease, Ulcerative Colitis and liver diseases. 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