Completed

Monoclonal Factor IX Concentrate for Factor IX Deficiency

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

monoclonal factor IX replacement therapy

Drug
Who is being recruted

Blood Coagulation Disorders+11

+ Hemic and Lymphatic Diseases

+ Hemorrhagic Disorders

Over 12 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: March 1992
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1992

Actual date on which the first participant was enrolled.

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.

NCT00004801
Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

3 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Coagulation DisordersHemic and Lymphatic DiseasesHemorrhagic DisordersCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and SymptomsCoagulation Protein DisordersDisease AttributesBlood Coagulation Disorders, InheritedGenetic Diseases, InbornGenetic Diseases, X-LinkedHemophilia BHematologic DiseasesRare Diseases

Criteria

PROTOCOL ENTRY CRITERIA: Patients with factor IX deficiency.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers