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
  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:


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
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, see Learn About Clinical Studies.

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

Sponsors and Collaborators
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 August 26, 2014