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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) University of North Carolina |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004801 |
OBJECTIVES:
Assess the safety and long-term efficacy of monoclonal factor IX concentrate in patients with factor IX deficiency.
Condition | Intervention | Phase |
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Hemophilia B Factor IX Deficiency |
Drug: monoclonal factor IX replacement therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Safety/Efficacy Study |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
Patients with factor IX deficiency.
Study ID Numbers: | 199/11956, UNCCH-621 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004801 |
Health Authority: | United States: Federal Government |
hematologic disorders rare disease |
Hemophilia B Hemorrhagic Disorders Genetic Diseases, Inborn Hematologic Diseases Blood Coagulation Disorders |
Hemophilia A Genetic Diseases, X-Linked Rare Diseases Hemostatic Disorders |
Blood Coagulation Disorders, Inherited Coagulation Protein Disorders |