CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 63 enrolled
Drug / intervention
catridecacogdrug
Likely dose
catridecacog 35 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00978380
NCT00978380Phase 3Completed
CompareCT.gov

A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Subjects With Congenital Factor XIII Deficiency

Novo Nordisk A/S·interventional·Posted Sep 16, 2009·Updated Jan 24, 2018

In Brief

A Phase 3 clinical trial evaluating catridecacog for Congenital Bleeding Disorder and Congenital FXIII Deficiency. Completed, enrolled 63 participants across 34 sites in 12 countries.

Detailed Summary

This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the safety of monthly replacement therapy of recombinant factor XIII in patients with congenital FXIII deficiency. The trial continues until the product is commercially available, but an interim assessment will take place when all subjects have completed 52 weeks in the trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Bleeding Disorder, Congenital FXIII Deficiency
CountriesAustria, Canada, Finland, France, Germany, Israel, Italy, Japan, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 16, 2009
Enrollment StartSep 21, 2009
Primary CompletionOct 20, 2015
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 16.8 years ago

Interventions

catridecacogdrug

Monthly administration of recombinant factor XIII as preventative treatment of bleeding episodes. Dose: 35 IU/kg body weight intravenous (into the vein)