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| Sponsor: | Archemix Corp. |
|---|---|
| Information provided by: | Archemix Corp. |
| ClinicalTrials.gov Identifier: | NCT00726544 |
Purpose
The purpose of this ascending-dose research study is to determine whether the administration of ARC1779 Injection improves subject's health profile by protecting the brain, heart, and kidney from damage due to formation of small blood clots in blood vessels. It will also determine the safety of ARC1779 Injection, how ARC1779 Injection enters and leaves the blood and tissue over time, and its effect on laboratory tests related to blood clotting, heart and brain function, and other body systems.
| Condition | Intervention | Phase |
|---|---|---|
|
Thrombotic Microangiopathy Thrombotic Thrombocytopenic Purpura |
Drug: ARC 1779 Placebo Drug: ARC1779 Injection |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-blind, Placebo Controlled, Clinical Outcome Study of ARC1779 Injection in Patients With Thrombotic Microangiopathy |
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo: Placebo Comparator |
Drug: ARC 1779 Placebo
ARC1779 Injection or placebo is administered intravenously to patients as an initial loading dose followed by continuous infusion of up to 14 days plus 2 day taper.
|
| Low Dose: Active Comparator |
Drug: ARC1779 Injection
ARC1779 Injection or placebo is administered intravenously to patients as an initial loading dose followed by continuous infusion of up to 14 days plus 2 day taper. Treatment with ARC1779 Injection is to be given at low dosage that is intended to produce target steady-state ARC1779 plasma concentrations during infusion of 3μg/mL.
|
| Medium Dose: Active Comparator |
Drug: ARC1779 Injection
ARC1779 Injection or placebo is administered intravenously to patients as an initial loading dose followed by continuous infusion of up to 14 days plus 2 day taper. Treatment with ARC1779 Injection is to be given at low dosage that is intended to produce target steady-state ARC1779 plasma concentrations during infusion of 6μg/mL.
|
| High Dose: Active Comparator |
Drug: ARC1779 Injection
ARC1779 Injection or placebo is administered intravenously to patients as an initial loading dose followed by continuous infusion of up to 14 days plus 2 day taper. Treatment with ARC1779 Injection is to be given at low dosage that is intended to produce target steady-state ARC1779 plasma concentrations during infusion of 12μg/mL.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who have again become acutely ill following recent treatment and achievement of a brief remission of acute TMA may be enrolled in the study if ALL of the following conditions are met:
Exclusion Criteria:
Patients who have again become acutely ill following recent treatment and achievement of a brief remission of acute TMA may not be enrolled in the study if ANY of the following conditions are met:
Contacts and Locations| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Indiana University Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Missouri | |
| Washington University | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| United States, Ohio | |
| The Ohio State University Research Foundation | |
| Columbus, Ohio, United States, 43235 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| Austria | |
| University of Vienna | |
| Vienna, Austria, 1090 | |
| Canada | |
| CHA-Hospital de L'Enfant-Jesus | |
| Quebec, Canada, G1J 1Z4 | |
| Canada, Nova Scotia | |
| QEII CDHA Centre | |
| Halifax, Nova Scotia, Canada, B3H 2Y9 | |
| Canada, Quebec | |
| CICM/Hospital Charles LeMoyne | |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| Italy | |
| Policlinico Mangiagalli Regina Elena-Fondazione L.Villa | |
| Milan, Italy | |
| Università Cattolica del Sacro Cuore | |
| Rome, Italy | |
| Ospedale Ferrarotto | |
| Catania, Italy, 95100 | |
| Fondazione Ospedale Maggiore Policlinico | |
| Milano, Italy, 20122 | |
| Azienda Ospedaliera S.Maria Nuova | |
| Reggio Emilia, Italy, 42100 | |
| United Kingdom | |
| University College London Hospital | |
| London, United Kingdom, W1T 4EU | |
More Information
| Responsible Party: | Archemix ( Dr, James Gilbert ) |
| Study ID Numbers: | ARC1779-006 |
| Study First Received: | July 30, 2008 |
| Last Updated: | November 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00726544 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Austria: Agency for Health and Food Safety; Switzerland: Swissmedic; Canada: Health Canada; Italy: Ministry of Health |
|
thrombocytopenia microangiopathic hemolytic anemia von Willebrand Factor ADAMTS13 |
|
Purpura Skin Manifestations Immune System Diseases Hematologic Diseases Thrombophilia Blood Coagulation Disorders Blood Platelet Disorders Vascular Diseases |
Purpura, Thrombotic Thrombocytopenic Thrombosis Purpura, Thrombocytopenic Signs and Symptoms Embolism and Thrombosis Thrombocytopenia Cardiovascular Diseases |