A Placebo-controlled Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis
|ClinicalTrials.gov Identifier: NCT01706159|
Recruitment Status : Terminated (Trial screening data did not support the medical hypothesis)
First Posted : October 15, 2012
Results First Posted : August 5, 2014
Last Update Posted : October 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Inflammation Ulcerative Colitis||Drug: catridecacog Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Randomised, Double-blind, Placebo-controlled, Multiple-dose Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Catridecacog (recombinant factor XIII, rFXIII) will be administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week at a dose of 35 IU/kg
Other Name: recombinant factor XIII
|Active Comparator: Placebo||
Placebo will be administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week.
- Endoscopic Remission Defined as a Modified Baron Score of 0 [ Time Frame: At week 8 ]The primary endpoint was the binary variable ("responder" vs. "non-responder") where "responders" were the subjects with endoscopic remission (endoscopic mucosal healing) at Week 8, defined as a modified Baron score of 0. Subjects with a modified Baron score ≥1 were designated as "non-responders".
- Remission (Clinical and Endoscopic) [ Time Frame: At Week 8 ]Analysis of responders defined by a clinical component of: ulcerative colitis disease activity index (UC-DAI) score of less than or equal to 1 with 0 for rectal bleeding and 0 for stool frequency and an endoscopic component of: no mucosal friability (modified Baron score less than or equal to 1).
- Number of Adverse Events (AEs) [ Time Frame: Week 0 to 10 ]Number of adverse events reported from the first trial-related activity, after the subject was exposed to the trial drug, until the end of the post-treatment follow-up period.
- Clearance (CL) of rFXIII [ Time Frame: Samples were collected before and up to 72 hours after the first dose of rFXIII. ]The volume of plasma cleared of the drug per unit time.
- Maximum Concentration (Cmax) of rFXIII [ Time Frame: Samples were collected before and up to 72 hours after the first dose of rFXIII. ]The peak plasma concentration of the drug after dose administration.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706159
|Rousse, Bulgaria, 7002|
|Zagreb, Croatia, 10000|
|Herlev, Denmark, 2730|
|Bekescsaba, Hungary, H5600|
|Lodz, Poland, 90-153|
|Nizhny Novgorod, Russian Federation, 60316|
|Kharkiv, Ukraine, 61000|
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk A/S|