Trials / Completed
CompletedNCT00004801
Phase I/II Study of Monoclonal Factor IX Concentrate for Factor IX Deficiency
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 3 (planned)
- Sponsor
- National Center for Research Resources (NCRR) · NIH
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | monoclonal factor IX replacement therapy |
Timeline
- Start date
- 1992-03-01
- First posted
- 2000-02-25
- Last updated
- 2005-06-24
Source: ClinicalTrials.gov record NCT00004801. Inclusion in this directory is not an endorsement.