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Safety, Pharmacokinetics and Efficacy of an ATIII Concentrate

NCT00319228 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-08-25

No results posted yet for this study

Summary

To assess the safety, pharmacokinetics and efficacy of a plasma-derived AT-III concentrate in the treatment of subjects with congenital AT-III deficiency.

Conditions

  • Antithrombin III Deficiency

Interventions

DRUG

Plasma-derived AT-III concentrate

Segment I: A single dose IV infusion of 50 IU/kg of ATIII-DAF/DI will be administered to each patient. Segment II: A single dose or multiple doses depending on the subject's ATIII plasma levels and patient's specific treatment plan.

Sponsors & Collaborators

  • Grifols Biologicals, LLC

    lead INDUSTRY

Principal Investigators

  • Paul Pinciaro, PhD · Grifols Biologicals, LLC

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2028-12-31
Completion
2029-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00319228 on ClinicalTrials.gov