Phase I/II Study of Monoclonal Factor IX Concentrate for Factor IX Deficiency

This study has been completed.

First Received on February 24, 2000. Last Updated on June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	University of North Carolina
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004801

Purpose

OBJECTIVES:

Assess the safety and long-term efficacy of monoclonal factor IX concentrate in patients with factor IX deficiency.

Condition	Intervention	Phase
Hemophilia B Factor IX Deficiency	Drug: monoclonal factor IX replacement therapy	Phase I Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia Help Me Understand Genetics

Drug Information available for: Factor IX

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	3
Study Start Date:	March 1992

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.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

Patients with factor IX deficiency.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004801

Sponsors and Collaborators

National Center for Research Resources (NCRR)

University of North Carolina

Investigators

Study Chair:

Gilbert C. White

University of North Carolina

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00004801 History of Changes
Other Study ID Numbers:	199/11956, UNCCH-621
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

hematologic disorders
rare disease

Additional relevant MeSH terms:

Hemophilia B
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases

Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked

ClinicalTrials.gov processed this record on February 12, 2012