Phase I/II Study of Monoclonal Factor IX Concentrate for Factor IX Deficiency
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00004801|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
Assess the safety and long-term efficacy of monoclonal factor IX concentrate in patients with factor IX deficiency.
|Condition or disease||Intervention/treatment||Phase|
|Hemophilia B Factor IX Deficiency||Drug: monoclonal factor IX replacement therapy||Phase 1 Phase 2|
Patients receive monoclonal factor IX replacement therapy as inpatients. Patients with a satisfactory response receive further therapy as needed for bleeding for up to 36 months at home.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||3 participants|
|Study Start Date :||March 1992|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004801
|Study Chair:||Gilbert C. White||University of North Carolina|