Quality of Life Study of Helixate NexGen

CSL Behring

Status: Completed

Conditions: Hemophilia A

Study type: Observational

Funder types: Industry

Identifiers

NCT01053715

CE1250_5002_EU

1501

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: Male

Ages: 14 to 35 years old

Volunteers: No Healthy Volunteers

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