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

NCT01706159 | Terminated Phase 2 Results

• 3 other identifiers: NN8717-39462011-001568-22U1111-1120-3824
• Study Type: interventional
• Target: 20
• Locations: 7 countries
• Sites: 7

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).

Conditions

Inflammation; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Remission (Clinical and Endoscopic)

  At Week 8

• Number of Adverse Events (AEs)

  Week 0 to 10

• Clearance (CL) of rFXIII

  Samples were collected before and up to 72 hours after the first dose of rFXIII.

• Maximum Concentration (Cmax) of rFXIII

  Samples were collected before and up to 72 hours after the first dose of rFXIII.

Study Arms (2)

rFXIII

EXPERIMENTAL

Drug: catridecacog

Placebo

ACTIVE COMPARATOR

Drug: placebo

Interventions

catridecacog DRUG

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

Also known as: recombinant factor XIII

rFXIII

placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (7)

Unknown Facility

Rousse, 7002, Bulgaria

Location

Unknown Facility

Zagreb, 10000, Croatia

Location

Unknown Facility

Herlev, 2730, Denmark

Location

Unknown Facility

Békéscsaba, H5600, Hungary

Location

Unknown Facility

Lodz, 90-153, Poland

Location

Unknown Facility

Nizhny Novgorod, 60316, Russia

Location

Unknown Facility

Kharkiv, 61000, Ukraine

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Inflammation; Colitis, Ulcerative

Interventions

recombinant factor XIII-A2

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Limitations and Caveats

The trial was terminated earlier than planned as the hypothesis of a correlation between low levels of FXIII and disease activity of UC could not be confirmed.

Results Point of Contact

• Title: Public Access to Clinical Trials
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: October 15, 2012
• Study Start: October 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 2, 2014
• Results First Posted: August 5, 2014

Record last verified: 2014-09

Locations

UA (1); DK (1); BU (1); PL (1); CR (1); RU (1); HU (1)