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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
Sponsor:
Collaborator:
University of North Carolina
Information provided by:
Office of Rare Diseases (ORD)

Brief Summary:

OBJECTIVES:

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

Detailed Description:

PROTOCOL OUTLINE:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 3 participants
Primary Purpose: Treatment
Study Start Date : March 1992






Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

Patients with factor IX deficiency.


Information from the National Library of Medicine

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


Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of North Carolina
Investigators
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Study Chair: Gilbert C. White University of North Carolina
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ClinicalTrials.gov Identifier: NCT00004801    
Other Study ID Numbers: 199/11956
UNCCH-621
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 1998
Keywords provided by Office of Rare Diseases (ORD):
hematologic disorders
rare disease
Additional relevant MeSH terms:
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Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked