Inflammatory Bowel Disease Clinical Trial
Official title:
A Double-blind, Randomized, Placebo-controlled Multicenter Study to Assess the Safety and Efficacy of AST-120 in Mild to Moderately Active Crohn's Patients With Fistulas
The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with mild to moderately severe Crohn's disease who have fistulas. The study will test whether or not patients receiving AST-120 experience a greater reduction in number of draining fistulas and improvement of their other Crohn's disease symptoms versus patients who receive placebo (material that does not contain any active medication).
Status | Completed |
Enrollment | 191 |
Est. completion date | September 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Univ Klinik fur Innere Medizin Innsbruck | Innsbruck | |
Austria | Universitatsklinik fur Innere Medizin I der PMU | Salzburg | |
Austria | AKH Wien - Univ Klinik Innere Med IV | Wien | |
Belgium | Imelda General Hospital | Bonheiden | |
Belgium | St. Jansziekenhuis/Ziekenhuis Oost-Limburg | Genk | |
Belgium | University Hospital Gasthuisberg, University of Leuven | Leuven | |
Belgium | H.-Hartziekenhuis Roeselare-Menen vzw | Roeselare | |
Canada | GILDR Group, University of Edmonton | Edmonton | Alberta |
Canada | McMaster University Medical Centre | Hamilton | Ontario |
Canada | London Health Sciences Center | London | Ontario |
Canada | Jewish General Hospital | Montreal | Quebec |
Canada | Liver & Intestinal Research Centre | Vancouver | British Columbia |
Czech Republic | University Hospital Brno, Internal and Gastroenterology Department | Brno | |
Czech Republic | Regional Hospital Liberec, Department of Gastroenterology | Liberec | |
Czech Republic | University Hospital Prague 2, 4th Department of Internal Medicine | Prague 2 | |
Czech Republic | Institute for Clinical and Experimental Medicine | Prague 4 | |
Czech Republic | Thomayer's University Hospital Prague, 2nd Internal Department | Prague 4 | |
France | CHU Hopital Nord, Service de Gastro-enterologie et nutrition | Amiens | |
France | Hopital de la Cote de Nacre - CHU | Caen | |
France | CHU de Grenoble - Hopital Nord | Grenoble | |
France | Hopital Claude Huriez, Service des maladies de l'appareil disgestif | Lille | |
France | Hopital Nord, Service de Gastro-Enterologie | Marseille | |
France | Hopital Saint-Eloi, Service de Gastro-enterologie et transplantation | Montpelier | |
France | CHU Hotel Dieu, Institut des Maladies de l'Appareil Digestif | Nantes | |
France | CHU de Nice - Hopital de l'Archet 2 | Nice | |
France | Hopital Leopold Bellan | Paris | |
Germany | Universitatsklinikum Aachen | Aachen | |
Germany | Charite-Campus Virchow-Klinikum | Berlin | |
Germany | Klinikum der Johann-Wolfgang-Goethe Universitat Frankfurt am Main | Frankfurt | |
Germany | Medizinische Hochschule Hannover | Hannover | |
Germany | Universitatsklinik Heidelberg Abteilung Gastroenterologie und Hepatologie | Heidelberg | |
Germany | Universitatsklinikum Schleswig-Holstein | Kiel | |
Germany | Klinikum rechts der Isar der TUM II | Munchen | |
Germany | Universitatsklinikum Regensburg | Regensburg | |
Germany | Universitat Rostock - Midizinische Fakultat | Rostock | |
Germany | Medizinische Universitatsklinik Tubingen | Tubingen | |
Germany | Universitatsklinikum Ulm | Ulm | |
Hungary | Peterfy Sandor utcai Korhaz-Rendelointezet | Budapest | |
Hungary | Semmelweis Egyetem | Budapest | |
Hungary | Semmelweis Egyetem | Budapest | |
Hungary | Miskolc Megyei Jogu Onkormanyzat Semmelweis Oktato Korhaz-Rendelointezet | Miskolc | |
Hungary | Szegedi Tudomanyegyetem, I.sz. Belgyogyaszati Klinika | Szeged | |
Israel | Bnai Zion Medical Center | Haifa | |
Israel | Rambam Medical Center | Haifa | |
Israel | Strauss Medical Center | Jerusalem | |
Israel | Meir Hospital | Kfar Saba | |
Israel | Rabin Medical Center, Bellinson Hospital | Petah Tikva | |
Israel | Sheba Medical Center | Ramat Gan | |
Israel | Kaplan Medical Center | Rehovot | |
Netherlands | Erasmus MC, Department of Gastroenterology and Hepatology | Rotterdam | |
Poland | Samodzielny Publiczny Centralny Szpital Kliniczny Slaskiej AM | Katowice | |
Poland | Zakaznych Szpitala Uniwersyteckiego w Krakowie | Krakow | |
Poland | Korektalnej Uniwersytetu Medycznego w Lodzi | Lodz | |
Poland | University Hospital Olomouc, 2nd Internal Department | Olomouc | |
Poland | Samodzielny Publiczny Szpital Kliniczny Nr 2 im. Heliodora | Poznan | |
Poland | Samodzielny Publiczny Centralny Szpital | Warszawa | |
Poland | Katedra Klinika Gastroenterologi, Akedemil Medycanej we Wroclawiu | Wroclaw | |
United Kingdom | Bristol Royal Infirmary, Dept. of Gastroenterology | Bristol | |
United Kingdom | Countess of Chester Hospital | Chester | |
United Kingdom | Crosshouse Hospital | Kilmarnock | |
United Kingdom | Leicester General Hospital - GI Research Unit | Leicester | |
United Kingdom | University College London Hospital, Dept. of Gastroenterology | London | |
United Kingdom | John Radcliffe Hospital, Dept. of Gastroenterology | Oxford | |
United States | Advanced Clinical Research Institute | Anaheim | California |
United States | Brigham & Women's Hospital | Boston | Massachusetts |
United States | University of North Carolina | Chapel Hill | North Carolina |
United States | Digestive Disease Center/MUSC | Charleston | South Carolina |
United States | Carolina Digestive Health Associates | Charlotte | North Carolina |
United States | Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan |
United States | Metropolitan Gastroenterology Group/Chevy Chase Clinical Research | Chevy Chase | Maryland |
United States | Rush University Medical Center | Chicago | Illinois |
United States | University of Chicago Medical Center | Chicago | Illinois |
United States | Cleveland Clinic - Department of Gastroenterology | Cleveland | Ohio |
United States | University Hospitals of Cleveland | Cleveland | Ohio |
United States | Drs. Scherf, Chessler, Zingler & Spinnell, MD, PA | Fort Lee | New Jersey |
United States | Memphis Gastroenterology Group, PC | Germantown | Tennessee |
United States | Long Island Clinical Research Associates, LLP | Great Neck | New York |
United States | The Penn State University, Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | Indiana University, Outpatient Clinical Research Facility | Indianapolis | Indiana |
United States | University of Kentucky Chandler Medical Center | Lexington | Kentucky |
United States | University of Louisville, Department of Surgery | Louisville | Kentucky |
United States | Dean Foundation Research Center | Madison | Wisconsin |
United States | Mount Sinai School of Medicine, IBD Research Center | New York | New York |
United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
United States | University of Rochester Medical Center | Rochester | New York |
United States | Digestive Care Medical Center | San Carlos | California |
United States | University of Washington | Seattle | Washington |
United States | Shafran Gasteroenterology Center | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
Ocera Therapeutics |
United States, Austria, Belgium, Canada, Czech Republic, France, Germany, Hungary, Israel, Netherlands, Poland, United Kingdom,
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Gray BK, Lockhartmummery HE, Morson BC. Crohn's disease of the anal region. Gut. 1965 Dec;6(6):515-24. — View Citation
Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P; ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541-9. — View Citation
Hay JW, Hay AR. Inflammatory bowel disease: costs-of-illness. J Clin Gastroenterol. 1992 Jun;14(4):309-17. — View Citation
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Ogura Y, Bonen DK, Inohara N, Nicolae DL, Chen FF, Ramos R, Britton H, Moran T, Karaliuskas R, Duerr RH, Achkar JP, Brant SR, Bayless TM, Kirschner BS, Hanauer SB, Nuñez G, Cho JH. A frameshift mutation in NOD2 associated with susceptibility to Crohn's disease. Nature. 2001 May 31;411(6837):603-6. — View Citation
Present DH, Korelitz BI, Wisch N, Glass JL, Sachar DB, Pasternack BS. Treatment of Crohn's disease with 6-mercaptopurine. A long-term, randomized, double-blind study. N Engl J Med. 1980 May 1;302(18):981-7. — View Citation
Present DH, Rutgeerts P, Targan S, Hanauer SB, Mayer L, van Hogezand RA, Podolsky DK, Sands BE, Braakman T, DeWoody KL, Schaible TF, van Deventer SJ. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med. 1999 May 6;340(18):1398-405. — View Citation
Sands BE, Anderson FH, Bernstein CN, Chey WY, Feagan BG, Fedorak RN, Kamm MA, Korzenik JR, Lashner BA, Onken JE, Rachmilewitz D, Rutgeerts P, Wild G, Wolf DC, Marsters PA, Travers SB, Blank MA, van Deventer SJ. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004 Feb 26;350(9):876-85. — View Citation
Schwartz DA, Herdman CR. Review article: The medical treatment of Crohn's perianal fistulas. Aliment Pharmacol Ther. 2004 May 1;19(9):953-67. Review. — View Citation
Schwartz DA, Loftus EV Jr, Tremaine WJ, Panaccione R, Harmsen WS, Zinsmeister AR, Sandborn WJ. The natural history of fistulizing Crohn's disease in Olmsted County, Minnesota. Gastroenterology. 2002 Apr;122(4):875-80. — View Citation
Schwartz DA, Pemberton JH, Sandborn WJ. Diagnosis and treatment of perianal fistulas in Crohn disease. Ann Intern Med. 2001 Nov 20;135(10):906-18. Review. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy: The proportion of patients considered to be "treatment successes" defined by a reduction of at least 50% in the number of draining fistulas at both week 4 and week 8 of an 8 week treatment period | 8 weeks | No | |
Primary | Safety: Adverse events deemed possibly, probably or definitely related to study drug during 8 weeks of treatment | 8 weeks | Yes | |
Secondary | Efficacy: 100% non-draining fistulas at both week 4 and week 8 | 8 weeks | No | |
Secondary | Efficacy: Fistula response at Week 8 | 8 weeks | No | |
Secondary | Efficacy: Change in CDAI scores from baseline over 8 weeks of treatment | 8 weeks | No | |
Secondary | Safety: Clinical laboratory tests (electrolytes) | 8 weeks | Yes | |
Secondary | Safety: Development of abscesses | 8 weeks | Yes | |
Secondary | Safety: Physical examination, vital signs (blood pressure, heart rate, respiration rate and temperature) | 8 weeks | Yes |
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