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

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).

Timeline

Start

2012-10

Primary completion

2013-07

Completion

2013-07

Outcome

Missed primary endpoint

Stopped: “Trial screening data did not support the medical hypothesis”

registry analysis (superiority or other test); rFXIII vs Placebo; p = 0.3056; Odds Ratio (OR) 0.16 (90% CI 0.01 to 3.05); NCT01706159 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	catridecacog	Protein / enzyme biologic	35 iu/kg	Intravenous

Indications