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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

1992-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

OBJECTIVES:

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hemophilia B Factor IX Deficiency

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

hematologic disorders rare disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

monoclonal factor IX replacement therapy

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

PROTOCOL ENTRY CRITERIA:

Patients with factor IX deficiency.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gilbert C. White

Role: STUDY_CHAIR

University of North Carolina

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UNCCH-621

Identifier Type: -

Identifier Source: secondary_id

199/11956