Brief Title
A Prospective Study to Collect High-Quality Documentation of Bleeds, Health-Related Quality of Life (HRQoL), and Safety Outcomes in Patients With Hemophilia A Treated With Standard-of-Care Treatment
Official Title
A Multicenter, Non-Interventional Study Evaluating Bleeding Incidence, Health-Related Quality of Life, and Safety in Patients With Hemophilia A Under Standard-of-Care Treatment
Brief Summary
This non-interventional study will prospectively collect detailed, high-quality documentation of bleeds, HRQoL, and safety in patients with hemophilia A with or without FVIII inhibitors treated according to local routine clinical practice (receiving FVIII replacement or bypassing agents as either episodic or prophylactic treatment). Actual patients will be enrolled from routine clinical practice in this observational study.
Study Type
Observational
Primary Outcome
Number of Bleeds
Secondary Outcome
European Quality of Life-5 Dimensions (EQ-5D-5L) Questionnaire Score Among Adult and Adolescent Patients
Condition
Hemophilia A
Intervention
Bypassing Agents
Study Arms / Comparison Groups
Cohort A: Adults and Adolescents with FVIII Inhibitors
Description: Adults and adolescents with hemophilia A of any severity with the presence of FVIII inhibitors will be observed.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
221
Start Date
May 26, 2015
Completion Date
March 31, 2017
Primary Completion Date
March 31, 2017
Eligibility Criteria
Inclusion Criteria: - Cohort A: Patients greater than or equal to (>/=) 12 years of age at time of informed consent - Cohort A: Diagnosis of congenital hemophilia A of any severity and documented history of high-titer inhibitor (that is, >/= 5 Bethesda units [BU]) - Cohort B: Pediatric patients less than (<) 12 years of age - Cohort B: Diagnosis of congenital hemophilia A of any severity and documented history of high-titer inhibitor (that is, >/=5 BU) - Cohort C: Patients >/=12 years of age - Cohort C: Diagnosis of congenital hemophilia A and FVIII activity <1 percent (%) - Cohort C: No prior history of a positive inhibitor against FVIII Exclusion Criteria: - Prior RO5534262 (not applicable if patient agrees that prior RO5534262 will preclude participation in a future investigational RO5534262 study) - Bleeding disorder other than congenital hemophilia A - Ongoing (or planned during the study) immune tolerance induction therapy with FVIII or FVIII prophylaxis if currently/previously exposed to an inhibitor - Previous or concomitant thromboembolic disease - Known human immunodeficiency virus (HIV) infection with cluster of differentiation (CD) 4 count <200 cells per microliter (cells/mcL)
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Clinical Trials, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT02476942
Organization ID
BH29768
Responsible Party
Sponsor
Study Sponsor
Hoffmann-La Roche
Study Sponsor
Clinical Trials, Study Director, Hoffmann-La Roche
Verification Date
May 2017