NCT00157118

Efficacy and Safety Study of Protein C Concentrate in Subjects With Severe Congenital Protein C Deficiency

A Phase II/III Clinical Study for the Determination of the Efficacy and Safety of Protein C Concentrate in Subjects With Severe Congenital Protein C Deficiency

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to show that Protein C Concentrate is a safe and effective treatment for subjects with congenital protein C deficiency. Depending on the type of treatment required, patients are assigned to one of 3 study parts: Part 1 is for the treatment of acute episodes, Part 2 is for short-term prophylaxis, and Part 3 is for long-term prophylaxis in infants aged less than 6 months only.

Conditions

• Protein C Deficiency

Interventions

Type	Name	Description
DRUG	Protein C Concentrate (Human) Vapor Heated

Timeline

• Start date: 2003-08-22
• Primary completion: 2005-03-17
• Completion: 2005-03-17
• First posted: 2005-09-12
• Last updated: 2021-05-05

Locations

12 sites across 1 country: United States