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Clinical Trials/NCT01053715
NCT01053715
Completed
Not Applicable

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

CSL Behring31 sites in 7 countries78 target enrollmentJanuary 2010
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ConditionsHemophilia A

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemophilia A
Sponsor
CSL Behring
Enrollment
78
Locations
31
Primary Endpoint
Health Related Quality of Life (HRQoL)
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
January 2015
Last Updated
11 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

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(Duration of the study)
  • Change in HRQoL due to transitional life events(Duration of the study)

Study Sites (31)

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