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NCT00157118 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of Protein C Concentrate in Subjects With Severe Congenital Protein C Deficiency
A Phase 2 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT00157118 is a Phase 2 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 18 participants.
The verdict
NCT00157118, a Phase 2 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study 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.
Interventions
- DRUG Protein C Concentrate (Human) Vapor Heated
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2003-08-22 |
| Est. Completion | 2005-03-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00157118
The ClinicalTrials.gov registry entry for NCT00157118 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Protein C Concentrate (Human) Vapor Heated is the first listed.
NCT00157118 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00157118 about?
NCT00157118 is a clinical study titled "Efficacy and Safety Study of Protein C Concentrate in Subjects With Severe Congenital Protein C Deficiency". 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 fo...
What is the current status of trial NCT00157118?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2003-08-22. Estimated completion is 2005-03-17.
What interventions are being tested in trial NCT00157118?
The interventions under investigation include: Protein C Concentrate (Human) Vapor Heated (DRUG).
Who is sponsoring clinical trial NCT00157118?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
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