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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief 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.

Detailed Summary:
Sponsor: Baxalta US Inc.

Current Primary Outcome: Whether episodes of purpura fulminans, Coumarin-induced skin necrosis and/or other thromboembolic event could be treated effectively, effectively with complications, or not treated effectively with Protein C Concentrate. [ Time Frame: Part 1 of the study ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Baxalta US Inc.

Dates:
Date Received: September 8, 2005
Date Started: August 2003
Date Completion:
Last Updated: June 26, 2015
Last Verified: July 2013