Quality of Life Study of Helixate NexGen

March 18, 2015 updated by: CSL Behring

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • CSLB Study Site 22
      • Grieskirchen, Austria
        • CSLB Study Site 26
      • Innsbruck, Austria
        • CSLB Study Site 24
      • Klagenfurt, Austria
        • CSLB Study Site 29
      • Linz, Austria
        • CSLB Study Site 23
      • St. Pölten, Austria
        • CSLB Study Site 25
      • Vienna, Austria
        • CSLB Study Site 20
      • Vienna, Austria
        • CSLB Study Site 21
      • Vienna, Austria
        • CSLB Study Site 27
  • Belgium
      • Edegem, Belgium
        • CSLB Study Site 52
      • Leuven, Belgium
        • CSLB Study Site 51
  • France
      • Amiens, France
        • CSLB Study Site 65
      • Poitiers Cedex, France
        • CSLB Study Site 68
      • Rouen, France
        • CSLB Study Site 60
      • Strasbourg, France
        • CSLB Study Site 64
      • Valence, France
        • CSLB Study Site 66
  • Germany
      • Berlin, Germany
        • CSLB Study Site 1
      • Bonn, Germany
        • CSLB Study Site 3
      • Bremen, Germany
        • CSLB Study Site 2
      • Delmenhorst, Germany
        • CSLB Study Site 6
      • Göttingen, Germany
        • CSLB Study Site 7
      • München, Germany
        • CSLB Study Site 4
  • Italy
      • Genova, Italy
        • CSLB Study Site 72
      • Milan, Italy
        • CSLB Study Site 71
      • Napoli, Italy
        • CSLB Study Site 74
      • Palermo, Italy
        • CSLB Study Site 73
  • Spain
      • Badajoz, Spain
        • CSLB Study Site 98
      • Jaen, Spain
        • CSLB Study Site 95
      • Valencia, Spain
        • CSLB Study Site 91
  • Switzerland
      • St. Gallen, Switzerland
        • CSLB Study Site 35
      • Zürich, Switzerland
        • CSLB Study Site 36

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 35 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with a diagnosis of moderate or severe Hemophilia A using Helixate NexGen identified by selected European hemophilia treatment centers.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSL Behring

Investigators

  • Principal Investigator: Robert Klamroth, MD, Hämophiliezentrum, Vivantes-Klinikum im Friedrichshain Zentrum für Gefäßmedizin, Berlin
  • Principal Investigator: Alessandro Gringeri, MD, I.R.C.C.S. Fondazione Ospedale Maggiore Policlinico, Milan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

January 20, 2010

First Submitted That Met QC Criteria

January 20, 2010

First Posted (ESTIMATE)

January 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 20, 2015

Last Update Submitted That Met QC Criteria

March 18, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE1250_5002_EU
  • 1501 (CSL Behring)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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