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

Phase 1

Completed

• Conditions: Hemophilia B; Factor IX Deficiency

• Registration Number: NCT00004801
• Lead Sponsor: National Center for Research Resources (NCRR)

Brief Summary

OBJECTIVES:

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

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.

Study Timeline

• Study Start: 1992-03
• Status Verified: 1998-01
• Study First Submitted: 2000-02-24
• Study First Submitted QC: 2000-02-24
• Study First Posted: 2000-02-25
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified