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: November 7, 2013
Last verified: November 2013
  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: recombinant factor XIII
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 ]

Secondary Outcome Measures:
  • Remission (clinical, endoscopic) [ Time Frame: At week 8 ] [ Designated as safety issue: No ]
  • Number of adverse events (AEs) [ Time Frame: Weeks 0 - 10 ] [ Designated as safety issue: No ]
  • Clearance (CL) systemically [ Time Frame: 0-72 hours after dosing ] [ Designated as safety issue: No ]
  • Maximal concentration (Cmax) systemically [ Time Frame: 0-72 hours after dosing ] [ Designated as safety issue: No ]

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: recombinant factor XIII
rFXIII will be administered as intravenous (i.v.) injections once every second week at a dose of 35 IU/kg
Active Comparator: Placebo Drug: placebo
Placebo will be administered as intravenous (i.v.) injections once every second week at a dose of 35 IU/kg

  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 for at least 6 weeks of at least 2g/day. 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706159

Locations
Bulgaria
Rousse, Bulgaria, 7002
Croatia
Zagreb, Croatia, 10000
Denmark
Hvidovre, Denmark, 2650
Hungary
Gyula, Hungary, H5700
Poland
Lodz, Poland, 90-302
Russian Federation
Lipetsk, Russian Federation, 398055
Ukraine
Knipropetrovsk, Ukraine, 49044
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: John Francisco 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
Last Updated: November 7, 2013
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:
Colitis
Colitis, Ulcerative
Inflammation
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014