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

This study has been completed.

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

Sponsors and Collaborators:	National Center for Research Resources (NCRR) 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

Genetics Home Reference related topics: hemophilia L1 syndrome

Drug Information available for: Factor IX

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Safety/Efficacy Study

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

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

Keywords provided by Office of Rare Diseases (ORD):

hematologic disorders
rare disease

Study placed in the following topic categories:

Hemophilia B
Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Blood Coagulation Disorders

Hemophilia A
Genetic Diseases, X-Linked
Rare Diseases
Hemostatic Disorders

Additional relevant MeSH terms:

Hemophilia B
Hemorrhagic Disorders
Blood Coagulation Disorders, Inherited
Genetic Diseases, Inborn
Coagulation Protein Disorders

Hematologic Diseases
Blood Coagulation Disorders
Hemophilia A
Genetic Diseases, X-Linked

ClinicalTrials.gov processed this record on May 07, 2009