We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

Brief Summary:


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:


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)
Estimated Enrollment : 3 participants
Primary Purpose: Treatment
Study Start Date : March 1992

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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


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
Study Chair: Gilbert C. White University of North Carolina

ClinicalTrials.gov Identifier: NCT00004801     History of Changes
Other Study ID Numbers: 199/11956
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:
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked