Brief Title
Quality of Life Study of Helixate NexGen
Official Title
A European, Prospective, Non-Interventional Study to Assess Health Related Quality of Life and to Identify Key Transitional Life Events in Patients With Moderate or Severe Haemophilia A Using Helixate NexGen
Brief Summary
The aim of this study is to describe Health Related Quality of Life (HRQoL) in adolescents and adults with Hemophilia A treated prophylactically or on-demand with Helixate NexGen. The study will also assess the kinds of determinants, including key transitional life events, that might impact HRQoL in this patient population.
Study Type
Observational
Primary Outcome
Health Related Quality of Life (HRQoL)
Secondary Outcome
Change in HRQoL due to pre-specified factors potentially affecting HRQoL in patients with hemophilia
Condition
Hemophilia A
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
78
Start Date
January 2010
Completion Date
January 2015
Primary Completion Date
January 2015
Eligibility Criteria
Inclusion Criteria: - Haemophilia A patient - Severely (<1%) and moderately (1-5%) affected - On treatment with Helixate NexGen - Ability to read and understand study materials (patient information and data protection form, patient-related questionnaires) - Signed data protection form; if patient is <18 years of age, legal guardian must also give written consent by signing the data protection form Exclusion Criteria: - Presence of inhibitors - Abuse of recreational drugs or alcohol interfering with the every-day-life in the opinion of the physician - Advanced stage human immunodeficiency virus (HIV) infection (CD4 cell counts <200/cmm, multi-drug resistance, presence of AIDS related signs or symptoms) - Symptomatic liver disease (cirrhosis, ascites, esophageal varices) - Concomitant or planned interferon therapy - Malignancies on or off treatment
Gender
Male
Ages
14 Years - 35 Years
Accepts Healthy Volunteers
No
Contacts
Robert Klamroth, MD, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT01053715
Organization ID
CE1250_5002_EU
Secondary IDs
1501
Responsible Party
Sponsor
Study Sponsor
CSL Behring
Study Sponsor
Robert Klamroth, MD, Principal Investigator, Hämophiliezentrum, Vivantes-Klinikum im Friedrichshain Zentrum für Gefäßmedizin, Berlin
Verification Date
March 2015