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NCT00004801 Clinical Trial

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

Hemophilia B Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004801
Other study ID # 199/11956
Secondary ID UNCCH-621
Status Completed
Phase Phase 1/Phase 2
First received February 24, 2000
Last updated June 23, 2005
Start date March 1992

Study information
Verified date January 1998
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

OBJECTIVES:

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 3
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility PROTOCOL ENTRY CRITERIA:

Patients with factor IX deficiency.

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• monoclonal factor IX replacement therapy

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) University of North Carolina
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