Safety and Efficacy of AST-120 in Mild to Moderate Crohn's Patients With Fistulas
Inflammatory Bowel Disease, Intestinal Fistula
About this trial
This is an interventional treatment trial for Inflammatory Bowel Disease focused on measuring Crohn's disease, IBD, Inflammatory Bowel Disease, Fistula
Eligibility Criteria
Inclusion Criteria: Body Weight > or = 40kg Documented diagnosis of Crohn's disease, including patients with documented diagnosis of ileitis, colitis, or ileocolitis Presence of at least one draining fistula. Patients with enterocutaneous fistulas can be included if they have > or = 1 draining perianal fistula. Women with rectovaginal fistulas can be included if they have > or = 1 draining perianal fistula. Crohn's Disease Activity Index (CDAI) score < 400 Platelet count (thrombocytes) > or = 100,000/uL Able and willing to comply with all protocol procedures for the duration of the study Able and willing to understand, sign and date an informed consent document, and authorize access to protected health information Females must be postmenopausal, surgically incapable of bearing children, or practicing a reliable method of birth control (hormonal contraceptives, intrauterine devices, spermicide and barrier). Partner/spouse sterility may also qualify at the Investigator's discretion. Females of child-bearing potential must have a negative urine pregnancy test at baseline. Exclusion Criteria: Non-response to infliximab or other biological immunosuppressants/ immunomodulators for fistulas associated with Crohn's disease (response is defined as a > or = 50% reduction from baseline in the number of fistulas over at least four weeks); patients who respond once to infliximab and eventually fail can be included Infliximab (and/or other biological immunosuppressant/immunomodulatory) therapy within 3 months prior to enrollment in the study Presence of symptomatic strictures or suggestion of significant clinical obstruction Patients with setons are excluded, unless the setons are removed within 48 hours prior to study entry Presence of entero-entero, recto-vesicular, entero-vesicular fistulas Platelet count (thrombocytes) < 100,000/uL CDAI score of > or = 400 Patient is unable to stay on a stable dose of concomitant Crohn's disease medication(s) for at least 10 weeks in the opinion of the investigator Currently symptomatic untreated diarrhea due to conditions other than mild to moderately active Crohn's disease (e.g., bacterial or parasitic gastroenteritis, bile salt diarrhea, etc.) Severe diarrhea defined by > 10 liquid bowel movements per day Other local manifestations of mild to moderately active Crohn's disease such as abscesses, or other disease manifestations for which surgery might be indicated or which might preclude utilization of a CDAI to assess response to therapy (e.g., short bowel syndrome) Presence of an ileostomy Receiving Total Parenteral Nutrition (TPN) as the sole source of nutrition within 3 weeks of Screen Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling. Hemoglobin < 8.5 g/dL (females) or hemoglobin < 10 g/dL (males) at Screen Women who are pregnant, breast feeding, or planning to become pregnant during the study Other major physical or major psychiatric illness within the last 6 months that in the opinion of the investigator would affect the patient's ability to complete the trial Uncontrolled systemic disease Patients undergoing chemotherapy for the treatment of cancer Known hypersensitivity or contraindication to any component of the test product (study drugs) or diagnostics used Participation in another study within eight (8) weeks prior to the study Unable to attend all visits required by the protocol
Sites / Locations
- Advanced Clinical Research Institute
- Digestive Care Medical Center
- Shafran Gasteroenterology Center
- Rush University Medical Center
- University of Chicago Medical Center
- Indiana University, Outpatient Clinical Research Facility
- University of Kentucky Chandler Medical Center
- University of Louisville, Department of Surgery
- Metropolitan Gastroenterology Group/Chevy Chase Clinical Research
- Brigham & Women's Hospital
- Clinical Research Institute of Michigan, LLC
- Drs. Scherf, Chessler, Zingler & Spinnell, MD, PA
- Long Island Clinical Research Associates, LLP
- Mount Sinai School of Medicine, IBD Research Center
- University of Rochester Medical Center
- University of North Carolina
- Carolina Digestive Health Associates
- University Hospitals of Cleveland
- Cleveland Clinic - Department of Gastroenterology
- The Penn State University, Milton S. Hershey Medical Center
- Allegheny General Hospital
- Digestive Disease Center/MUSC
- Memphis Gastroenterology Group, PC
- University of Washington
- Dean Foundation Research Center
- Univ Klinik fur Innere Medizin Innsbruck
- Universitatsklinik fur Innere Medizin I der PMU
- AKH Wien - Univ Klinik Innere Med IV
- Imelda General Hospital
- St. Jansziekenhuis/Ziekenhuis Oost-Limburg
- University Hospital Gasthuisberg, University of Leuven
- H.-Hartziekenhuis Roeselare-Menen vzw
- GILDR Group, University of Edmonton
- Liver & Intestinal Research Centre
- McMaster University Medical Centre
- London Health Sciences Center
- Jewish General Hospital
- University Hospital Brno, Internal and Gastroenterology Department
- Regional Hospital Liberec, Department of Gastroenterology
- University Hospital Prague 2, 4th Department of Internal Medicine
- Thomayer's University Hospital Prague, 2nd Internal Department
- Institute for Clinical and Experimental Medicine
- CHU Hopital Nord, Service de Gastro-enterologie et nutrition
- Hopital de la Cote de Nacre - CHU
- CHU de Grenoble - Hopital Nord
- Hopital Claude Huriez, Service des maladies de l'appareil disgestif
- Hopital Nord, Service de Gastro-Enterologie
- Hopital Saint-Eloi, Service de Gastro-enterologie et transplantation
- CHU Hotel Dieu, Institut des Maladies de l'Appareil Digestif
- CHU de Nice - Hopital de l'Archet 2
- Hopital Leopold Bellan
- Universitatsklinikum Aachen
- Charite-Campus Virchow-Klinikum
- Klinikum der Johann-Wolfgang-Goethe Universitat Frankfurt am Main
- Medizinische Hochschule Hannover
- Universitatsklinik Heidelberg Abteilung Gastroenterologie und Hepatologie
- Universitatsklinikum Schleswig-Holstein
- Klinikum rechts der Isar der TUM II
- Universitatsklinikum Regensburg
- Universitat Rostock - Midizinische Fakultat
- Medizinische Universitatsklinik Tubingen
- Universitatsklinikum Ulm
- Peterfy Sandor utcai Korhaz-Rendelointezet
- Semmelweis Egyetem
- Semmelweis Egyetem
- Miskolc Megyei Jogu Onkormanyzat Semmelweis Oktato Korhaz-Rendelointezet
- Szegedi Tudomanyegyetem, I.sz. Belgyogyaszati Klinika
- Bnai Zion Medical Center
- Rambam Medical Center
- Strauss Medical Center
- Meir Hospital
- Rabin Medical Center, Bellinson Hospital
- Sheba Medical Center
- Kaplan Medical Center
- Erasmus MC, Department of Gastroenterology and Hepatology
- Samodzielny Publiczny Centralny Szpital Kliniczny Slaskiej AM
- Zakaznych Szpitala Uniwersyteckiego w Krakowie
- Korektalnej Uniwersytetu Medycznego w Lodzi
- University Hospital Olomouc, 2nd Internal Department
- Samodzielny Publiczny Szpital Kliniczny Nr 2 im. Heliodora
- Samodzielny Publiczny Centralny Szpital
- Katedra Klinika Gastroenterologi, Akedemil Medycanej we Wroclawiu
- Bristol Royal Infirmary, Dept. of Gastroenterology
- Countess of Chester Hospital
- Crosshouse Hospital
- Leicester General Hospital - GI Research Unit
- University College London Hospital, Dept. of Gastroenterology
- John Radcliffe Hospital, Dept. of Gastroenterology
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
2
1
Celphere® CP-305, stained to match appearance of AST-120, in 2g sachets
AST-120, 2 gram sachets