NCT02408484

Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin in Paediatric Subjects With Fibrinogen Deficiency

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Octapharma · Industry
• Sex: All
• Age: 11 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the efficacy of Octafibrin, a fibrinogen concentrate in in the on-demand treatment of spontaneous or traumatic bleeding episodes in paediatric patients less than 12 years of age.The planned study duration is up to 5 years. The study will be considered completed when a minimum of 6 subjects (i.e., at least 3 subjects aged between 0 and \<6 years and 3 subjects aged between 6 and \<12 years) have at least one documented bleeding episode and when in total a minimum of 2 surgical procedures have been performed. All patients will undergo a pharmacokinetic (PK) study after screening. This will have a duration of 14 days, after which a patient can be treated for a bleeding episode or planned surgical procedure when they occur.

Conditions

• Congenital Fibrinogen Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	Octafibrin	Plasma-derived Fibrinogen concentrate

Timeline

• Start date: 2015-12-01
• Primary completion: 2019-06-11
• Completion: 2019-06-11
• First posted: 2015-04-03
• Last updated: 2021-01-15
• Results posted: 2020-06-11

Locations

4 sites across 3 countries: India, Iran, Lebanon