Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery

Congenital Fibrinogen Deficiency Clinical Trial

Official title:
Prospective, Open-label, Uncontrolled, Phase III Study to Assess the Efficacy and Safety of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery in Subjects With Congenital Fibrinogen Deficiency

Status Completed

Clinical Trial Summary

The purpose of the study is to assess the efficacy and safety of Octafibrin for on-demand treatment of acute bleeding in subjects with congenital fibrinogen deficiency.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02267226
Study type	Interventional
Source	Octapharma
Contact
Status	Completed
Phase	Phase 3
Start date	September 2014
Completion date	February 14, 2018

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See also
Status	Clinical Trial	Phase
Completed	`NCT02427217` - An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency	N/A
Completed	`NCT01575756` - Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap	Phase 2
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