Quality of Life Study of Helixate NexGen

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.

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

14 year–35 year

Sex eligibility

Male

Study type

Observational

Primary location

CSLB Study Site 22, Graz, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Health Related Quality of Life (HRQoL)

Time frame: baseline and every 12 months over 3 years

Secondary outcomes

Change in HRQoL due to pre-specified factors potentially affecting HRQoL in patients with hemophilia

Time frame: Duration of the study
Change in HRQoL due to transitional life events

Time frame: Duration of the study

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Jan 21, 2010
Registry last updated: Mar 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed