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

This study has been terminated.
(Trial screening data did not support the medical hypothesis)
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01706159
First received: October 9, 2012
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Inflammation
Ulcerative Colitis
Drug: catridecacog
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Endoscopic Remission Defined as a Modified Baron Score of 0 [ Time Frame: At week 8 ] [ Designated as safety issue: No ]
    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) [ Time Frame: At Week 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    The peak plasma concentration of the drug after dose administration.


Enrollment: 20
Study Start Date: October 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, 61037
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01706159     History of Changes
Other Study ID Numbers: NN8717-3946, 2011-001568-22, U1111-1120-3824
Study First Received: October 9, 2012
Results First Received: July 10, 2014
Last Updated: July 10, 2014
Health Authority: Bulgaria: Ministry of Health
Croatia: Ministry of Health and Social Care
Denmark: Danish Medicines Agency
Hungary: Ministry of Health, Social and Family Affairs
Poland: Ministry of Health
Ukraine: Ministry of Health Ukraine
Russia: Federal Service for Control of Health Care and Social Development

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

ClinicalTrials.gov processed this record on September 18, 2014