Back to resultsA Placebo-controlled Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis
Primary Purpose
Inflammation, Ulcerative Colitis
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
catridecacog
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of ulcerative colitis for at least 3 months from the time of initial diagnosis. The diagnosis must have been confirmed by historical endoscopy and histology. The severity of disease must have been confirmed by endoscopy at screening
- Currently receiving oral aminosalicylates at approved doses of at least 2g/day for at least 6 weeks. Doses of oral aminosalicylates should be stable for at least two weeks prior to dosing (Visit 2)
Exclusion Criteria:
- Diagnosis of UC limited to the rectum (ulcerative proctitis only, defined as less than 15 cm from the anal verge)
- Requiring hospitalisation for current episode of severe UC
- Use of biologic therapies for the treatment of UC within 12 weeks prior to dosing (Visit 2)
- Treatment failures to anti-tumour necrosis factor-alfa (anti-TNF-a) agents (e.g. infliximab, adalimumab)
- Use of immunosuppressant agents (e.g. azathioprine) within 4 weeks prior to dosing (Visit 2)
- Use of corticosteroids (oral, intravenous (i.v.), intramuscular (i.m.), or rectal ) within 14 days prior to dosing (Visit 2)
- Use of enemas (corticosteroid or aminosalicylate) within 14 days prior to screening (Visit 1)
- Use of cyclosporine, tacrolimus, D-penicillamine, leflunomide, methotrexate, mycophenolate mofetil, or thalidomide within 4 weeks prior to dosing (Visit 2)
- Currently receiving total parenteral nutrition
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
rFXIII
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Endoscopic Remission Defined as a Modified Baron Score of 0
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".
Secondary Outcome Measures
Remission (Clinical and Endoscopic)
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)
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
The volume of plasma cleared of the drug per unit time.
Maximum Concentration (Cmax) of rFXIII
The peak plasma concentration of the drug after dose administration.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01706159
Brief Title
A Placebo-controlled Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis
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 Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Why Stopped
Trial screening data did not support the medical hypothesis
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is conducted in Europe. The aim of the trial is to investigate the effect of recombinant factor XIII (rFXIII) administered to subjects with mild to moderate active ulcerative colitis (UC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rFXIII
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
catridecacog
Other Intervention Name(s)
recombinant factor XIII
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo will be administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week.
Primary Outcome Measure Information:
Title
Endoscopic Remission Defined as a Modified Baron Score of 0
Description
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".
Time Frame
At week 8
Secondary Outcome Measure Information:
Title
Remission (Clinical and Endoscopic)
Description
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).
Time Frame
At Week 8
Title
Number of Adverse Events (AEs)
Description
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.
Time Frame
Week 0 to 10
Title
Clearance (CL) of rFXIII
Description
The volume of plasma cleared of the drug per unit time.
Time Frame
Samples were collected before and up to 72 hours after the first dose of rFXIII.
Title
Maximum Concentration (Cmax) of rFXIII
Description
The peak plasma concentration of the drug after dose administration.
Time Frame
Samples were collected before and up to 72 hours after the first dose of rFXIII.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of ulcerative colitis for at least 3 months from the time of initial diagnosis. The diagnosis must have been confirmed by historical endoscopy and histology. The severity of disease must have been confirmed by endoscopy at screening
Currently receiving oral aminosalicylates at approved doses of at least 2g/day for at least 6 weeks. Doses of oral aminosalicylates should be stable for at least two weeks prior to dosing (Visit 2)
Exclusion Criteria:
Diagnosis of UC limited to the rectum (ulcerative proctitis only, defined as less than 15 cm from the anal verge)
Requiring hospitalisation for current episode of severe UC
Use of biologic therapies for the treatment of UC within 12 weeks prior to dosing (Visit 2)
Treatment failures to anti-tumour necrosis factor-alfa (anti-TNF-a) agents (e.g. infliximab, adalimumab)
Use of immunosuppressant agents (e.g. azathioprine) within 4 weeks prior to dosing (Visit 2)
Use of corticosteroids (oral, intravenous (i.v.), intramuscular (i.m.), or rectal ) within 14 days prior to dosing (Visit 2)
Use of enemas (corticosteroid or aminosalicylate) within 14 days prior to screening (Visit 1)
Use of cyclosporine, tacrolimus, D-penicillamine, leflunomide, methotrexate, mycophenolate mofetil, or thalidomide within 4 weeks prior to dosing (Visit 2)
Currently receiving total parenteral nutrition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
City
Rousse
ZIP/Postal Code
7002
Country
Bulgaria
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
City
Bekescsaba
ZIP/Postal Code
H5600
Country
Hungary
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
City
Nizhny Novgorod
ZIP/Postal Code
60316
Country
Russian Federation
City
Kharkiv
ZIP/Postal Code
61000
Country
Ukraine
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
A Placebo-controlled Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis
We'll reach out to this number within 24 hrs