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
- Conditions
- The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum.
- Registration Number
- EUCTR2005-005363-28-CZ
- Lead Sponsor
- Ocera Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
Age 18 to 70 years;
Body weight = 40 kg;
Documented diagnosis of Crohn’s disease, including patients with documented diagnosis of ileitis, colitis, or ileocolitis;
Presence of at least one draining perianal fistula. Patients with enterocutaneous fistulas can be included if they have = 1 draining perianal fistula. Women with rectovaginal fistulas can be included if they have = 1 draining perianal fistula;
CDAI score < 400;
Platelet count (thrombocytes) = 100,000/µL;
Able and willing to comply with all protocol procedures for the planned duration of the study;
Able and willing to understand, sign and date an informed consent document, and authorize access to protected health information.
In addition, a female patient must meet the following criteria:
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Non-response to infliximab or other biological immunosuppressants/ immunomodulators for fistulas associated with Crohn’s disease (response is defined as a = 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/µL;
CDAI score of = 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;
Females whose hemoglobin < 8.5 g/dL or males whose hemoglobin < 10 g/dL at screen;
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.
In addition, a female patient must be EXCLUDED if:
Pregnant, breast feeding, or planning to become pregnant during the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to evaluate the safety and efficacy of AST-120 in the treatment of mild to moderately severe fistulizing Crohn’s disease.;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint of this study is 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.<br><br>Patients who discontinue or meet treatment failure” criteria prior to Week 8 will not be considered to be treatment successes”.<br><br>The primary safety endpoint of this study is adverse events (AEs) deemed possibly, probably, or definitely related to treatment with investigational product during the initial 8 weeks of treatment.
- Secondary Outcome Measures
Name Time Method