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Safety and Efficacy of AST-120 in Mild to Moderate Crohn's Patients With Fistulas

Primary Purpose

Inflammatory Bowel Disease, Intestinal Fistula

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AST-120
Sponsored by
Ocera Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Placebo Comparator

Experimental

Arm Label

2

1

Arm Description

Celphere® CP-305, stained to match appearance of AST-120, in 2g sachets

AST-120, 2 gram sachets

Outcomes

Primary Outcome Measures

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
Safety: Adverse events deemed possibly, probably or definitely related to study drug during 8 weeks of treatment

Secondary Outcome Measures

Efficacy: 100% non-draining fistulas at both week 4 and week 8
Efficacy: Fistula response at Week 8
Efficacy: Change in CDAI scores from baseline over 8 weeks of treatment
Safety: Clinical laboratory tests (electrolytes)
Safety: Development of abscesses
Safety: Physical examination, vital signs (blood pressure, heart rate, respiration rate and temperature)

Full Information

First Posted
May 1, 2006
Last Updated
May 27, 2014
Sponsor
Ocera Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00321412
Brief Title
Safety and Efficacy of AST-120 in Mild to Moderate Crohn's Patients With Fistulas
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocera Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
The experimental drug AST-120 is composed of black, odorless spherical carbon particles in 2g sachets (aluminum foil pouches). The placebo consists of microcrystalline cellulose spheres, Celphere CP-305, stained to match the appearance of AST-120, in 2g sachets (aluminum foil pouches). Both AST-120 and placebo are oral (taken by mouth)preparations. Both are tasteless. To take the product, patients will tear open the sachets, drop the contents directly on their tongue and wash it down with 8 ounces of water. Patients will be randomly assigned (like the toss of a coin), to receive either AST-120 or placebo. Patients will have a 50/50 chance of receiving placebo. Patients who participate in this study will be required to take a single dose of study drug (AST-120 or placebo) 3 times a day, 30 minutes after a meal, for 8 weeks, and be evaluated at Week 4 and Week 8. This is a 'blinded' treatment, which means that neither the patient nor the study doctor will know if the patient has received study drug or placebo. If, at the end of the first full course of randomized treatment, (8 weeks), patients are not showing an improvement in their condition, they may have the option to receive the alternate blinded treatment for one treatment course (8 weeks). The study doctor will discuss this option with each patient individually. During this second course of treatment, patients will be evaluated at Week 12 and Week 16. If the patient does not respond to the alternate blinded treatment, or their condition worsens after 4 weeks (assessed at Week 12), they may be removed from the study at the discretion of the investigator. If patients respond to either the initial treatment or the alternate blinded treatment, they will have monthly doctor/clinic visits for up to 6 months (Week 24), or until their condition worsens or they relapse. Patients will not receive any study drug during this follow-up period. Relapse is defined for this study as: an increase by 1 or more in the number of draining fistulas for 2 sequential visits versus the number present at the time of response (response is defined as at least a 50% reduction in the number of draining fistulas at either Week 8, or for those patients receiving alternate blinded treatment, Week 16). There are a maximum of 8 patient evaluation visits in this study (Screen, Baseline, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24). Evaluations at most of these visits include a review of concomitant medications, medical history/adverse events, physical exam, fistula exam, blood draws for safety labs, urine pregnancy tests for females, and measurement of body weight. Patients will also be asked to keep a daily diary to record frequency of bowel movements, general well-being, and use of antidiarrheal medication. Treatment failure in this study is defined by one or more of the following occurring prior to Week 8: The need for additional therapies or dose increase for treatment of Crohn's disease, including an increase of corticosteroid dose to higher than baseline Clinical/symptomatic development of an abscess Clinical/symptomatic evidence of stricture The need for surgical intervention for Crohn's disease The patient withdraws from the study Patients will be discontinued from the study at any time if one or more of the following complications occur: Development of an abscess or symptomatic stricture The need for surgical intervention for Crohn's disease Occurrence of any other event that in the opinion of the investigator warrants discontinuation of the patient from the study In addition, patients whose CDAI score has risen by > or = 70 points above baseline or risen above 400 will be discontinued from the study. Administration of any additional therapies or dose increases of concomitant medications (including corticosteroids) to control Crohn's disease to higher than baseline while receiving study drug (initial randomized treatment or alternate blinded treatment) will require discontinuation of the patient from the study. Discontinued patients will be evaluated in a termination visit to document the lack of treatment efficacy and no further study treatment will be given.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Intestinal Fistula
Keywords
Crohn's disease, IBD, Inflammatory Bowel Disease, Fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
191 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Celphere® CP-305, stained to match appearance of AST-120, in 2g sachets
Arm Title
1
Arm Type
Experimental
Arm Description
AST-120, 2 gram sachets
Intervention Type
Drug
Intervention Name(s)
AST-120
Intervention Description
oral, sachet, 2 grams three times daily for 8 weeks
Primary Outcome Measure Information:
Title
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
Time Frame
8 weeks
Title
Safety: Adverse events deemed possibly, probably or definitely related to study drug during 8 weeks of treatment
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Efficacy: 100% non-draining fistulas at both week 4 and week 8
Time Frame
8 weeks
Title
Efficacy: Fistula response at Week 8
Time Frame
8 weeks
Title
Efficacy: Change in CDAI scores from baseline over 8 weeks of treatment
Time Frame
8 weeks
Title
Safety: Clinical laboratory tests (electrolytes)
Time Frame
8 weeks
Title
Safety: Development of abscesses
Time Frame
8 weeks
Title
Safety: Physical examination, vital signs (blood pressure, heart rate, respiration rate and temperature)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Fischer, MD
Organizational Affiliation
Ocera Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Digestive Care Medical Center
City
San Carlos
State/Province
California
ZIP/Postal Code
94070
Country
United States
Facility Name
Shafran Gasteroenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1426
Country
United States
Facility Name
Indiana University, Outpatient Clinical Research Facility
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Louisville, Department of Surgery
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Metropolitan Gastroenterology Group/Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Clinical Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Drs. Scherf, Chessler, Zingler & Spinnell, MD, PA
City
Fort Lee
State/Province
New Jersey
ZIP/Postal Code
07024
Country
United States
Facility Name
Long Island Clinical Research Associates, LLP
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Mount Sinai School of Medicine, IBD Research Center
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Carolina Digestive Health Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic - Department of Gastroenterology
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Penn State University, Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Digestive Disease Center/MUSC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Memphis Gastroenterology Group, PC
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Dean Foundation Research Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
Univ Klinik fur Innere Medizin Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Universitatsklinik fur Innere Medizin I der PMU
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
AKH Wien - Univ Klinik Innere Med IV
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Imelda General Hospital
City
Bonheiden
ZIP/Postal Code
B-2820
Country
Belgium
Facility Name
St. Jansziekenhuis/Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
University Hospital Gasthuisberg, University of Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
H.-Hartziekenhuis Roeselare-Menen vzw
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
GILDR Group, University of Edmonton
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
Liver & Intestinal Research Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H2
Country
Canada
Facility Name
McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
London Health Sciences Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
University Hospital Brno, Internal and Gastroenterology Department
City
Brno
ZIP/Postal Code
625 00
Country
Czech Republic
Facility Name
Regional Hospital Liberec, Department of Gastroenterology
City
Liberec
ZIP/Postal Code
460 63
Country
Czech Republic
Facility Name
University Hospital Prague 2, 4th Department of Internal Medicine
City
Prague 2
ZIP/Postal Code
120 00
Country
Czech Republic
Facility Name
Thomayer's University Hospital Prague, 2nd Internal Department
City
Prague 4
ZIP/Postal Code
140 00
Country
Czech Republic
Facility Name
Institute for Clinical and Experimental Medicine
City
Prague 4
ZIP/Postal Code
140 21
Country
Czech Republic
Facility Name
CHU Hopital Nord, Service de Gastro-enterologie et nutrition
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Hopital de la Cote de Nacre - CHU
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHU de Grenoble - Hopital Nord
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hopital Claude Huriez, Service des maladies de l'appareil disgestif
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Nord, Service de Gastro-Enterologie
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
Hopital Saint-Eloi, Service de Gastro-enterologie et transplantation
City
Montpelier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Hotel Dieu, Institut des Maladies de l'Appareil Digestif
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Nice - Hopital de l'Archet 2
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital Leopold Bellan
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Universitatsklinikum Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Charite-Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
D-13353
Country
Germany
Facility Name
Klinikum der Johann-Wolfgang-Goethe Universitat Frankfurt am Main
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
D-30623
Country
Germany
Facility Name
Universitatsklinik Heidelberg Abteilung Gastroenterologie und Hepatologie
City
Heidelberg
ZIP/Postal Code
D-69120
Country
Germany
Facility Name
Universitatsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
D-24105
Country
Germany
Facility Name
Klinikum rechts der Isar der TUM II
City
Munchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitatsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93047
Country
Germany
Facility Name
Universitat Rostock - Midizinische Fakultat
City
Rostock
ZIP/Postal Code
D-18057
Country
Germany
Facility Name
Medizinische Universitatsklinik Tubingen
City
Tubingen
ZIP/Postal Code
D-72026
Country
Germany
Facility Name
Universitatsklinikum Ulm
City
Ulm
ZIP/Postal Code
D-89081
Country
Germany
Facility Name
Peterfy Sandor utcai Korhaz-Rendelointezet
City
Budapest
ZIP/Postal Code
H-1076
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
H-1083
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
H-1088
Country
Hungary
Facility Name
Miskolc Megyei Jogu Onkormanyzat Semmelweis Oktato Korhaz-Rendelointezet
City
Miskolc
ZIP/Postal Code
H-3501
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem, I.sz. Belgyogyaszati Klinika
City
Szeged
ZIP/Postal Code
H-6701
Country
Hungary
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Strauss Medical Center
City
Jerusalem
ZIP/Postal Code
95146
Country
Israel
Facility Name
Meir Hospital
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Rabin Medical Center, Bellinson Hospital
City
Petah Tikva
ZIP/Postal Code
48100
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Erasmus MC, Department of Gastroenterology and Hepatology
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Samodzielny Publiczny Centralny Szpital Kliniczny Slaskiej AM
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Zakaznych Szpitala Uniwersyteckiego w Krakowie
City
Krakow
ZIP/Postal Code
31-531
Country
Poland
Facility Name
Korektalnej Uniwersytetu Medycznego w Lodzi
City
Lodz
ZIP/Postal Code
90-647
Country
Poland
Facility Name
University Hospital Olomouc, 2nd Internal Department
City
Olomouc
ZIP/Postal Code
775 20
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 2 im. Heliodora
City
Poznan
ZIP/Postal Code
06-355
Country
Poland
Facility Name
Samodzielny Publiczny Centralny Szpital
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Katedra Klinika Gastroenterologi, Akedemil Medycanej we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-326
Country
Poland
Facility Name
Bristol Royal Infirmary, Dept. of Gastroenterology
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Countess of Chester Hospital
City
Chester
ZIP/Postal Code
CH2 1UL
Country
United Kingdom
Facility Name
Crosshouse Hospital
City
Kilmarnock
ZIP/Postal Code
KA2 0BE
Country
United Kingdom
Facility Name
Leicester General Hospital - GI Research Unit
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
University College London Hospital, Dept. of Gastroenterology
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
John Radcliffe Hospital, Dept. of Gastroenterology
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom

12. IPD Sharing Statement

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Safety and Efficacy of AST-120 in Mild to Moderate Crohn's Patients With Fistulas

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