Clinical trial NCT01706159: A Placebo-controlled Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Inflammation
Ulcerative Colitis
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-10-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Endoscopic Remission Defined as a Modified Baron Score of 0
timeFrame: At week 8
Secondary outcomes:
measure: Remission (Clinical and Endoscopic)
timeFrame: At Week 8
measure: Number of Adverse Events (AEs)
timeFrame: Week 0 to 10
measure: Clearance (CL) of rFXIII
timeFrame: Samples were collected before and up to 72 hours after the first dose of rFXIII.
measure: Maximum Concentration (Cmax) of rFXIII
timeFrame: Samples were collected before and up to 72 hours after the first dose of rFXIII.
Other outcomes:
Locations:
city: Rousse
country: Bulgaria
city: Zagreb
country: Croatia
city: Herlev
country: Denmark
city: Bekescsaba
country: Hungary
city: Lodz
country: Poland
city: Nizhny Novgorod
country: Russian Federation
city: Kharkiv
country: Ukraine
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: