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

Tracking Information

First Received Date ^ICMJE

February 24, 2000

Last Updated Date

June 23, 2005

Start Date ^ICMJE

March 1992

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004801 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Safety/Efficacy Study

Condition ^ICMJE

Hemophilia B
Factor IX Deficiency

Intervention ^ICMJE

Drug: monoclonal factor IX replacement therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

PROTOCOL ENTRY CRITERIA:

Patients with factor IX deficiency.

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004801

Responsible Party

Study ID Numbers ^ICMJE

199/11956, UNCCH-621

Study Sponsor ^ICMJE

National Center for Research Resources (NCRR)

Collaborators ^ICMJE

University of North Carolina

Investigators ^ICMJE

Study Chair:

Gilbert C. White

University of North Carolina

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

January 1998

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP