CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 6 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/NCT01230021
NCT01230021Phase 3Completed
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A Phase 3b Trial Investigating the Pharmacokinetics and Safety Profile of a Single Intravenous Dose of rFXIII in Paediatric (1 to Less Than 6 Years Old) Subjects With Congenital FXIII A-subunit Deficiency

Novo Nordisk A/S·interventional·Posted Oct 28, 2010·Updated Feb 24, 2017

In Brief

A Phase 3 clinical trial evaluating catridecacog for Congenital Bleeding Disorder and Congenital FXIII Deficiency. Completed, enrolled 6 participants across 10 sites in 3 countries.

Detailed Summary

This trial is conducted in Europe and United States of America (USA). The aim of this clinical trial is to investigate the pharmacokinetics (at which rate the substance is distributed and eliminated from the body) and the safety profile of catridecacog (recombinant factor XIII (rFXIII)) in children with congenital FXIII A-subunit deficiency. Young children (1 to less than 6 years old) with congenital FXIII deficiency are evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Bleeding Disorder, Congenital FXIII Deficiency
CountriesIsrael, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 28, 2010
Enrollment StartNov 1, 2010
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.7 years ago

Interventions

catridecacogdrug

Intravenous injection of a single dose of recombinant factor XIII, 35 IU/kg bodyweight