Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap

Congenital Fibrinogen Deficiency Clinical Trial

Official title:
A Prospective, Controlled, Randomised, Crossover Study Investigating the Pharmacokinetic Properties, Surrogate Efficacy and Safety of Octafibrin Compared to Haemocomplettan® P/RiaSTAPTM in Patients With Congenital Fibrinogen Deficiency

Status Completed

Clinical Trial Summary

The purpose of this study is to investigate pharmacokinetic properties, surrogate efficacy and safety of Octafibrin compared to Haemocomplettan® P/RiaSTAPTM in patients with congenital fibrinogen deficiency

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01575756
Study type	Interventional
Source	Octapharma
Contact
Status	Completed
Phase	Phase 2
Start date	June 2013
Completion date	January 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02267226` - Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery	Phase 3
Completed	`NCT02427217` - An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency	N/A
Recruiting	`NCT03793426` - Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency
Completed	`NCT02408484` - Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin in Paediatric Subjects With Fibrinogen Deficiency	Phase 3