Quality of Life Study of Helixate NexGen

Completed

• Conditions: Hemophilia A

• Registration Number: NCT01053715
• Lead Sponsor: CSL Behring

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-18
• Last Update Posted: 2015-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 78

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (31)

CSLB Study Site 25; 🇦🇹 St. Pölten, Austria

CSLB Study Site 23; 🇦🇹 Linz, Austria

CSLB Study Site 65; 🇫🇷 Amiens, France

CSLB Study Site 60; 🇫🇷 Rouen, France

CSLB Study Site 68; 🇫🇷 Poitiers Cedex, France

CSLB Study Site 66; 🇫🇷 Valence, France

CSLB Study Site 1; 🇩🇪 Berlin, Germany

CSLB Study Site 64; 🇫🇷 Strasbourg, France

CSLB Study Site 3; 🇩🇪 Bonn, Germany

CSLB Study Site 2; 🇩🇪 Bremen, Germany

CSLB Study Site 6; 🇩🇪 Delmenhorst, Germany

CSLB Study Site 7; 🇩🇪 Göttingen, Germany

CSLB Study Site 4; 🇩🇪 München, Germany

CSLB Study Site 71; 🇮🇹 Milan, Italy

CSLB Study Site 73; 🇮🇹 Palermo, Italy

CSLB Study Site 95; 🇪🇸 Jaen, Spain

CSLB Study Site 98; 🇪🇸 Badajoz, Spain

CSLB Study Site 91; 🇪🇸 Valencia, Spain

CSLB Study Site 22; 🇦🇹 Graz, Austria

CSLB Study Site 26; 🇦🇹 Grieskirchen, Austria

CSLB Study Site 24; 🇦🇹 Innsbruck, Austria

CSLB Study Site 27; 🇦🇹 Vienna, Austria

CSLB Study Site 52; 🇧🇪 Edegem, Belgium

CSLB Study Site 51; 🇧🇪 Leuven, Belgium

CSLB Study Site 29; 🇦🇹 Klagenfurt, Austria

CSLB Study Site 20; 🇦🇹 Vienna, Austria

CSLB Study Site 21; 🇦🇹 Vienna, Austria

CSLB Study Site 35; 🇨🇭 St. Gallen, Switzerland

CSLB Study Site 36; 🇨🇭 Zürich, Switzerland

CSLB Study Site 74; 🇮🇹 Napoli, Italy

CSLB Study Site 72; 🇮🇹 Genova, Italy