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Completed Phase 2Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00157118

Public ClinicalTrials.gov record NCT00157118. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 9:58 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00157118
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Baxalta now part of Shire
Industry
Enrollment
18 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 22, 2003 (Actual)
Primary completion
Mar 17, 2005 (Actual)
Completion
Mar 17, 2005 (Actual)
Last update posted
May 5, 2021

2003 – 2005

United States locations

U.S. sites
12
U.S. states
8
U.S. cities
12
Facility City State ZIP Site status
Not listed Los Angeles California — —
Not listed Denver Colorado — —
Not listed Atlanta Georgia — —
Not listed Indianapolis Indiana — —
Not listed Lexington Kentucky — —
Not listed Boston Massachusetts — —
Not listed Cincinnati Ohio — —
Not listed Cleveland Ohio — —
Not listed Dayton Ohio — —
Not listed Fort Worth Texas — —
Not listed Galveston Texas — —
Not listed Houston Texas — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00157118, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 5, 2021 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00157118 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →