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Sponsored by: |
Grifols Biologicals Inc. |
Information provided by: | Grifols Biologicals Inc. |
ClinicalTrials.gov Identifier: | NCT00319228 |
To assess the safety, pharmacokinetics and efficacy of a plasma-derived AT-III concentrate in the treatment of subjects with congenital AT-III deficiency.
Condition | Intervention | Phase |
Antithrombin III Deficiency |
Drug: Plasma-derived AT-III concentrate |
Phase II Phase III |
Genetics Home Reference related topics: | aceruloplasminemia factor V Leiden thrombophilia hemophilia |
ChemIDplus related topics: | Antithrombin III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II/III Pivotal Trial Evaluating the Safety, Pharmacokinetic Properties and Efficacy of a Plasma-Derived Anti-Thrombin III Concentrate With Administration in Surgery, Pregnancy and Thromboembolic or Thrombotic Events. |
Estimated Enrollment: | 30 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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.
This study will be a prospective, unblinded, non-randomized, open-label, multi-center Phase II/III study with 2 segments, i.e. a PK evaluation (Segment I), and an assessment of prophylaxis in surgical interventions and pregnancy/delivery, (Segment II). During the PK segment, the subjects would remain on their current anticoagulation therapy except for subjects on heparin therapy where a wash-out period of at least 5 half lives would be required. In total, 15 subjects with congenital ATIII Deficiency will be enrolled for the PK assessment (Segment I).
For Segment II, fifteen episodes will be treated. Recruitment of individual subjects with high risk for venous thrombosis for Segment II of this study is necessary because of the rarity of Antithrombin deficiency in the population.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Paul J Pinciaro, PhD | 443-375-8825 | paul.pinciaro@grifols.com |
United States, District of Columbia | |||||
Georgetown University Medical Center | Recruiting | ||||
Washington, District of Columbia, United States, 20007 | |||||
Contact: Liza Vitug 202-687-3821 lmv3@georgetown.edu | |||||
Principal Investigator: Craig Kessler, MD | |||||
United States, New York | |||||
New York Presbyterian Hospital-Weill Cornell | Not yet recruiting | ||||
New York, New York, United States, 10021 | |||||
Contact: Dan Matulich dam2027@med.cornell.edu | |||||
Principal Investigator: Maria DeSancho, MD | |||||
United States, Ohio | |||||
Cleveland Clinic Foundation | Recruiting | ||||
Cleveland, Ohio, United States, 44195 | |||||
Contact: Yvette Ellis 216-444-9814 ellisy@ccf.org | |||||
Principal Investigator: Bernard Silver, MD | |||||
United States, Texas | |||||
University of Texas Health Science Center | Recruiting | ||||
Houston, Texas, United States, 77030-4009 | |||||
Contact: Kathryn L. Moynihan 713-500-8376 kathryn.l.moynihan@uth.tmc.edu | |||||
Contact: Madeline Cantini 713-500-8377 madeline.cantini@uth.tmc.edu | |||||
Principal Investigator: Deborah Brown, MD | |||||
United States, Virginia | |||||
University of Virginia Health System | Recruiting | ||||
Charlottesville, Virginia, United States, 22908-1370 | |||||
Contact: Winsor D. Simmons, RN 434-243-0315 wds5j@virginia.edu | |||||
Principal Investigator: Gail B. Macik, MD |
Grifols Biologicals Inc. |
Principal Investigator: | Keith Hoots, MD | University of Texas |
Responsible Party: | Grifols ( Paul J. Pinciaro, PhD/Director of Clinical Development ) |
Study ID Numbers: | IG-401 |
First Received: | April 26, 2006 |
Last Updated: | May 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00319228 |
Health Authority: | United States: Food and Drug Administration |
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