Asphelia Trichuris Suis Ova in Moderately Active Crohn's Disease

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2008
INTERVENTION: 15ml(167eggs/ml) oral Asp1002 (Trichuris Suis Ova [Tso]) taken every fortnight for 12 weeks. CONDITION: Crohn's Disease PRIMARY OUTCOME: percentage of patients who achieve response (reduction of CDAI[Crohn's Disease Activity Index] of ? 100 points) by Week 12, Primary Outcome: Safety and Tolerability of ASP1002 (TSO) SECONDARY OUTCOME: need for additional CD medications percentage of patients with healed ileal and colonic mucosa at Week 12 based on the Crohn?s disease endoscopic index of severity (CDEIS), time to response and remission To Evaluate Clinical Responseexamine immunological and inflammatory biomarkers, faecal samples and clinical response of ASP1002 (TSO) INCLUSION CRITERIA: 1. Diagnosis of CD involving the ileum, colon, or ileum and colon of at least 6 months in duration as determined by medical history 2. CDAI (Crohn's Disease Activity Index)= 220 and = 350, as scored from 7 days during the Screening period 3. Must have had colonoscopy with no significant findings and with findings consistent with CD within 6 months of study entry (Week 0) 4. Male or female, age 18 to 70 years, inclusive 5. If on the following medications at Screening Visit 1, patients must meet the following criteria: a. Corticosteroids: stable treatment for at least 4 weeks prior to study entry (Week 0) with a maximum dose of 15 mg/day b. Immunosuppressants [azathioprine (AZA), 6‐mercaptopurine (6‐MP), methotrexate (MTX)]: treatment for at least 3 months with a stable dose for four weeks prior to study entry (Week 0) c. Antibiotics: ciprofloxacin can be continued at a stable dose fo
Epistemonikos ID: 0e42d88c44c0c21675606559e19b7f897bb4c73f
First added on: Aug 21, 2024