Quality of Life Study of Helixate NexGen

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01053715

Enrollment

Registered

2010-01-21

Start date

2010-01-31

Completion date

2015-01-31

Last updated

2015-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Keywords

Hemophilia, Quality of Life

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

14 Years to 35 Years

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

Design outcomes

Primary

Measure	Time frame
Health Related Quality of Life (HRQoL)	baseline and every 12 months over 3 years

Secondary

Measure	Time frame
Change in HRQoL due to pre-specified factors potentially affecting HRQoL in patients with hemophilia	Duration of the study
Change in HRQoL due to transitional life events	Duration of the study

Countries

Austria, Belgium, France, Germany, Italy, Spain, Switzerland

Outcome results