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

January 20, 2010
July 2, 2014
January 2010
December 2014   (final data collection date for primary outcome measure)
Health Related Quality of Life (HRQoL) [ Time Frame: baseline and every 12 months over 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01053715 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Hemophilia A
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Male
14 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   France,   Germany,   Italy,   Spain,   Switzerland
 
NCT01053715
CE1250_5002_EU, 1501
No
CSL Behring
CSL Behring
Not Provided
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
CSL Behring
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP