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A Placebo-controlled Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis

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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
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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).

Condition or disease Intervention/treatment Phase
Inflammation Ulcerative Colitis Drug: catridecacog Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: rFXIII Drug: catridecacog
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 Drug: placebo
Placebo will be administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week.



Primary Outcome Measures :
  1. 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".


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706159


Locations
Bulgaria
Rousse, Bulgaria, 7002
Croatia
Zagreb, Croatia, 10000
Denmark
Herlev, Denmark, 2730
Hungary
Bekescsaba, Hungary, H5600
Poland
Lodz, Poland, 90-153
Russian Federation
Nizhny Novgorod, Russian Federation, 60316
Ukraine
Kharkiv, Ukraine, 61000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01706159     History of Changes
Other Study ID Numbers: NN8717-3946
2011-001568-22 ( EudraCT Number )
U1111-1120-3824 ( Other Identifier: WHO )
First Posted: October 15, 2012    Key Record Dates
Results First Posted: August 5, 2014
Last Update Posted: October 2, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Inflammation
Colitis
Ulcer
Colitis, Ulcerative
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases