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

National Center for Research Resources (NCRR)3 enrolled

Overview

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

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

Purpose

TREATMENT

Enrollment

Conditions

Hemophilia B Factor IX Deficiency

Interventions

monoclonal factor IX replacement therapyDRUG

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

PROTOCOL ENTRY CRITERIA: Patients with factor IX deficiency.

Data from ClinicalTrials.gov

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