Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis (NCT01953354) | Clinical Trial Compass
TerminatedPhase 2
Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis
Stopped: MFR's business decision to d/c TSO production -unrelated to any safety concern.
United States16 participantsStarted 2013-11
Plain-language summary
The purpose of this study is to evaluate the safety and effectiveness of trichuris suis ova (TSO) in ulcerative colitis (UC). We will look at how TSO affects the body's immune response and if there are related changes in participants' UC.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Subject has provided written informed consent
✓. Diagnosis of UC (newly diagnosed or established patients) as determined by medical history, endoscopic and histological confirmation with the proximal disease extent limited to the left colon (distal to the splenic flexure), and accessible by flexible sigmoidoscopy. Patients with left-sided disease and the presence of a periappendiceal red patch (limited cecal inflammation) will be eligible as long as there is no intervening evidence of colitis between the cecal base and the upper boundary of inflammation in the left colon.
✓. Mayo score \>/= 4, as scored at Screen 2
✓. If taking the following medications at Screen 1, subjects must meet the following criteria:
✓. Oral Corticosteroids: stable treatment for at least 4 weeks prior to Day 0 with a maximum dose equivalent to \<\\=15 mg/day of prednisone
✓. Immunosuppressants (azathioprine (AZA) or 6-mercaptopurine (6-MP)): treatment for at least 12 weeks with a stable dose, not exceeding 2.5 mg/kg/day of AZA or 1.5 mg/kg/day of 6-MP, during the 4 weeks prior to Day 0
✓. Aminosalicylates: stable oral doses up to 4.8 g/day for at least 4 weeks prior to Day 0.
Exclusion criteria
✕. Subjects whose UC is anticipated to require surgical, endoscopic, or radiologic intervention during study participation
✕. Uncontrolled GI bleeding
✕. Subjects who have disease limited to the rectum (maximum disease extent of less than 15 cm)
What they're measuring
1
Percentage of Participants Who Achieved a Clinical Response at Week 12
Timeframe: Week 12
Trial details
NCT IDNCT01953354
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕. Women who are pregnant, breast-feeding, or planning to become pregnant during the study. All women of childbearing potential must have a negative serum pregnancy test at Screen 2 prior to randomization of treatment.
✕. Women of childbearing potential not using adequate birth control measures (e.g., total abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization, Depo-Provera, or hormonal implants).
✕. Current or recent serious systemic disorder including clinically significant impairment in cardiac, pulmonary, liver, renal, endocrine, hematologic, or neurologic function, based on investigator discretion
✕. Subjects currently receiving the following concomitant medications:
✕. Prednisone or its equivalent at unstable doses or at doses exceeding 15 mg/day within 4 weeks prior to Day 0