Human Fibrinogen Concentrate (FGTW) in Pediatric Patients With Congenital Fibrinogen 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

PHASE2/PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-12-31

Brief Summary

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

The aim of the study is to evaluate clinical pharmacology, efficacy and safety of FGTW in pediatric patients with congenital fibrinogen deficiency.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacokinetic Study of Lipo-PGE1 for Prevention of VOD After HSCT

NCT02338440

Veno-occlusive Disease Child

UNKNOWN PHASE2/PHASE3

Different Doses of IVIG for Kawasaki Disease

NCT02439996

Kawasaki Disease

COMPLETED PHASE3

Non-Interventional (Observational) Post-Authorization Safety Study of HES 130/0.42 in Paediatric Patients

NCT00806533

Surgery

COMPLETED

Effectiveness of Intravenous Immunoglobulins (IVIG) in Toxic Shock Syndromes in Children

NCT02899702

Staphylococcal Infection Streptococcal Infection

WITHDRAWN PHASE4

Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support

NCT02980666

Short Bowel Syndrome

COMPLETED PHASE3

Detailed Description

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

Conditions

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

Hypofibrinogenemia, Congenital Afibrinogenemia, Congenital

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FGTW

Group Type EXPERIMENTAL

biological: human fibrinogen concentrate

Intervention Type DRUG

Interventions

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

biological: human fibrinogen concentrate

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Signed and dated informed consent form by parents or a legal representative
* Age less or equal to 12 years old
* Patients with inherited afibrinogenemia or severe inherited hypofibrinogenemia
* Negative results on HCG-based pregnancy test for females of childbearing potential (presence of menstruation)

Exclusion Criteria

* Dysfibrinogenemia
* Acquired fibrinogen deficiency
* Suspected present or past anticoagulation inhibitor
* Personal history of venous or arterial thrombosis or thromboembolic event
* Co-morbidity with other/unrelated coagulopathies
* Administration of any fibrinogen concentrate or fibrinogen containing blood product during the last 15 days
* Permanent treatment with antithrombotic or anti-platelet agents such as heparins, anti-IIa or anti-Xa agents, aspirin, clopidogrel and NSAIDs.

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No