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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004801

Enrollment

Registered

2000-02-25

Start date

1992-03-31

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Factor IX Deficiency, Hemophilia B

Keywords

hematologic disorders, rare disease

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.

Interventions

DRUGmonoclonal factor IX replacement therapy

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

PROTOCOL ENTRY CRITERIA: Patients with factor IX deficiency.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026