Evaluation of the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Patients With Severe Hemophilia A

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

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-11-30

Brief Summary

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

Understanding how often the bleeding events occur in the subjects who voluntarily decide to switch from prophylaxis to on-demand and in those subjects who remain on prophylaxis. Also look into the consequences of switching treatment in QoL (quality of life), development of target joints, activity level and reasons that might influence the desire to switch.

Related Clinical Trials

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

Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subjects Compared to That of Episodic Treatment

NCT00623480

Hemophilia A

COMPLETED PHASE3

Prophylaxis Versus on Demand Treatment for Children With Hemophilia A

NCT01810666

Hemophilia A

COMPLETED PHASE4

Patient Functioning and Well-being, Economic, and Clinical Impact of Hemophilia A and Its Treatment

NCT02396862

Hemophilia A

COMPLETED

A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A

NCT01233258

Hemophilia A

COMPLETED PHASE3

Comparison of Efficacy, Safety and Costs of Recombinant FVIII Products Between On-demand and Secondary Prophylaxis Groups in Haemophilia A Patients

NCT01817868

Hemophilia

COMPLETED

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.

Hematologic Disease Blood Coagulation Disorders

Study Design

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

Observational Model Type

COHORT

Study Groups

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

Group 1

Recombinant Factor VIII (Kogenate, BAY 14-2222)

Intervention Type BEHAVIORAL

Subjects electing to stay on the prophylactic treatment (prospective)

Group 2

Recombinant Factor VIII (Kogenate, BAY 14-2222)

Intervention Type BEHAVIORAL

Subjects electing to switch to on-demand treatment (prospective)

Group 3

Recombinant Factor VIII (Kogenate, BAY 14-2222)

Intervention Type BEHAVIORAL

Subjects remaining on-demand treatment (retrospective)

Interventions

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

Recombinant Factor VIII (Kogenate, BAY 14-2222)

Subjects electing to stay on the prophylactic treatment (prospective)

Intervention Type BEHAVIORAL

Recombinant Factor VIII (Kogenate, BAY 14-2222)

Subjects electing to switch to on-demand treatment (prospective)

Intervention Type BEHAVIORAL

Recombinant Factor VIII (Kogenate, BAY 14-2222)

Subjects remaining on-demand treatment (retrospective)

Intervention Type BEHAVIORAL

Eligibility Criteria

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

Inclusion Criteria

* Severe hemophilia A (\<2%)
* For subjects who elect staying on Prophylaxis only: Have been on continuous prophylactic treatment for the past 5 years prior to study entry
* For subjects who elect switching to on-demand only: Have been on continuous prophylactic treatment for the past 5 years, but may have been on intermediate or reduced prophylaxis for the 1-12 months prior to study entry
* For subjects currently on-demand: a retrospective arm of subjects who have been on continuous prophylactic treatment for at least 5 years and switched to on-demand treatment between 13 and 24 months prior to study entry
* Current treatment with rFVIII

Exclusion Criteria

* Other known hematological / bleeding disorders other than hemophilia A
* Participating on another study that may have an impact on bleeding or the objectives of this study
* Known alcohol and drug abuse

Minimum Eligible Age

14 Years

Maximum Eligible Age

29 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No