Phase I/II Study of Monoclonal Factor IX Concentrate for Factor IX Deficiency
June 23, 2005 updated by: National Center for Research Resources (NCRR)
OBJECTIVES:
Assess the safety and long-term efficacy of monoclonal factor IX concentrate in patients with factor IX deficiency.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
3
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
PROTOCOL ENTRY CRITERIA:
Patients with factor IX deficiency.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Gilbert C. White, University of North Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 1992
Study Registration Dates
First Submitted
February 24, 2000
First Submitted That Met QC Criteria
February 24, 2000
First Posted (Estimate)
February 25, 2000
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
January 1, 1998
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 199/11956
- UNCCH-621
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.