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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004801
First Posted: February 25, 2000
Last Update Posted: December 9, 2005
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.
Collaborator:
University of North Carolina
Information provided by:
Office of Rare Diseases (ORD)
  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 1 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


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

Information from the National Library of Medicine

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

PROTOCOL ENTRY CRITERIA:

Patients with factor IX deficiency.

  Contacts and Locations
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
Study Chair: Gilbert C. White University of North Carolina
  More Information

ClinicalTrials.gov Identifier: NCT00004801     History of Changes
Other Study ID Numbers: 199/11956
UNCCH-621
First Submitted: February 24, 2000
First Posted: February 25, 2000
Last Update Posted: December 9, 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