Clinical trial NCT00321412 (phase 3, status: completed)
Conditions: inflammatory bowel disease, intestinal fistula
ICD codes: M06.4, G61.89, G61.9, M35.81, G61.81, K75.9, M27.2
Drugs: ast-120
SMILES: [C]
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