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

NCT00004801 | Completed Phase 1

• 2 other identifiers: 199/11956UNCCH-621
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief Summary

OBJECTIVES: Assess the safety and long-term efficacy of monoclonal factor IX concentrate in patients with factor IX deficiency.

Conditions

Hemophilia B; Factor IX Deficiency

Keywords

hematologic disorders; rare disease

Interventions

monoclonal factor IX replacement therapy DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

PROTOCOL ENTRY CRITERIA: Patients with factor IX deficiency.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead
• University of North Carolina: collaborator

MeSH Terms

Conditions

Hemophilia B; Hematologic Diseases; Rare Diseases

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gilbert C. White

  University of North Carolina

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: March 1, 1992
• Last Updated: June 24, 2005

Record last verified: 1998-01