Quality of Life Study of Helixate NexGen

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT01053715
First received: January 20, 2010
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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.


Condition
Hemophilia A

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • Health Related Quality of Life (HRQoL) [ Time Frame: baseline and every 12 months over 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HRQoL due to pre-specified factors potentially affecting HRQoL in patients with hemophilia [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
  • Change in HRQoL due to transitional life events [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   14 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053715

Locations
Austria
CSLB Study Site 22
Graz, Austria
CSLB Study Site 26
Grieskirchen, Austria
CSLB Study Site 24
Innsbruck, Austria
CSLB Study Site 29
Klagenfurt, Austria
CSLB Study Site 23
Linz, Austria
CSLB Study Site 25
St. Pölten, Austria
CSLB Study Site 27
Vienna, Austria
CSLB Study Site 21
Vienna, Austria
CSLB Study Site 20
Vienna, Austria
Belgium
CSLB Study Site 52
Edegem, Belgium
CSLB Study Site 51
Leuven, Belgium
France
CSLB Study Site 65
Amiens, France
CSLB Study Site 68
Poitiers Cedex, France
CSLB Study Site 60
Rouen, France
CSLB Study Site 64
Strasbourg, France
CSLB Study Site 66
Valence, France
Germany
CSLB Study Site 1
Berlin, Germany
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
Italy
CSLB Study Site 72
Genova, Italy
CSLB Study Site 71
Milan, Italy
CSLB Study Site 74
Napoli, Italy
CSLB Study Site 73
Palermo, Italy
Spain
CSLB Study Site 98
Badajoz, Spain
CSLB Study Site 95
Jaen, Spain
CSLB Study Site 91
Valencia, Spain
Switzerland
CSLB Study Site 35
St. Gallen, Switzerland
CSLB Study Site 36
Zürich, Switzerland
Sponsors and Collaborators
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
  More Information

Additional Information:
No publications provided

Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT01053715     History of Changes
Other Study ID Numbers: CE1250_5002_EU, 1501
Study First Received: January 20, 2010
Last Updated: July 2, 2014
Health Authority: Austria: Ethikkommission
Italy: Ethics Committee
Germany: Ethics Commission
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Belgium: Ethics Committee
Spain: Ethics Committee
Switzerland: Swissmedic
Greece: National Organization of Medicines
Greece: Ethics Committee

Keywords provided by CSL Behring:
Hemophilia
Quality of Life

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014