Efficacy & Safety Study of Protein C Concentrate in Subjects With Severe

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial 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.

See also
	Status	Clinical Trial	Phase
	Completed	`NCT01127529` - Ceprotin Treatment Registry
	Completed	`NCT00161720` - Retrospective Study to Capture Dosing and Treatment Outcome Data in Participants With Severe Congenital Protein C Deficiency Who Were Treated With Protein C Concentrate Under an Emergency Use IND
	Not yet recruiting	`NCT04180657` - Ghrelin Levels in Patients With Protein C Deficiency

NCT number	NCT00157118
Study type	Interventional
Source	Takeda
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	August 22, 2003
Completion date	March 17, 2005

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms