Early Phase II clinical trial of PC-SOD -Study of the efficacy and safety of PC-SOD in patients with ulcerative colitis
- Conditions
- lcerative colitis(UC-DAI:more than 4)
- Registration Number
- JPRN-UMIN000000753
- Lead Sponsor
- TT Bio-Pharma Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
(1)Exclusion criteria with respect to efficacy 1)Patients who were diagnosed as rectitis type by spread of a pathological change (2)Exclusion criteria with respect to prior treatment 1)Patients who initiated steroid administration or remarkably changed the usage and dosage of it within 14 days prior to the investigational new drug 2)Patients who initiated administration of immunosuppressive drugs(azathioprine, mercaptopurine) 3)Patients who were treated with ciclosporin within 30 days prior to the administration of the investigational new drug 4)Patients who were treated with leukocyte removal therapy within 14 days prior to the administration of the investigational new drug (3)Exclusion criteria with respect to safety 1)Patients with renal damage (more than Grade 2) 2)Patients with liver damage 3)Patients who have complicated severe cardiovascular, respiratory, hematological diseases 4)Patients who have complicated neoplasms like cancers, tumors and so on 5)Patients who are pregnant or have possibility of pregnancy and under breast-feeding 6)Patients who attended any other clinical within four months prior to this trial 7)Patients who, in the opinion of the principal investigator or investigators are not likely to participate in the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method