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

National Center for Research Resources (NCRR)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hemophilia B; Factor IX Deficiency

Treatments: Drug: monoclonal factor IX replacement therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004801

UNCCH-621

199/11956

Details and patient eligibility

About

OBJECTIVES:

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

Full 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.

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

PROTOCOL ENTRY CRITERIA:

Patients with factor IX deficiency.