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

This study has been completed.
Sponsor:
Collaborator:
University of North Carolina
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004801
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: January 1998
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment

Resource links provided by NLM:

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 May 16, 2013