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

Inflammation Clinical Trial

Official title:

A Multicenter, Randomised, Double-blind, Placebo-controlled, Multiple-dose Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01706159
• Other study ID #: NN8717-3946
• Secondary ID: 2011-001568-22U1
• Status: Terminated
• Phase: Phase 2
• First received: October 9, 2012
• Last updated: September 22, 2014
• Start date: October 2012
• Est. completion date: July 2013

Study information

• Verified date: September 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Ministry of HealthCroatia: Ministry of Health and Social CareDenmark: Danish Medicines AgencyHungary: Ministry of Health, Social and Family AffairsPoland: Ministry of HealthUkraine: Ministry of Health UkraineRussia: Federal Service for Control of Health Care and Social Development
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammation
• Ulcer
• Ulcerative Colitis

Intervention

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
• placebo
Placebo will be administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Bulgaria,  Croatia,  Denmark,  Hungary,  Poland,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	At week 8	No
Secondary	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).	At Week 8	No
Secondary	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.	Week 0 to 10	No
Secondary	Clearance (CL) of rFXIII	The volume of plasma cleared of the drug per unit time.	Samples were collected before and up to 72 hours after the first dose of rFXIII.	No
Secondary	Maximum Concentration (Cmax) of rFXIII	The peak plasma concentration of the drug after dose administration.	Samples were collected before and up to 72 hours after the first dose of rFXIII.	No

External Links

•   Clinical Trials at Novo Nordisk