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NCT01053715 Clinical Trial

Quality of Life Study of Helixate NexGen

Hemophilia A Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01053715
Other study ID # CE1250_5002_EU
Secondary ID 1501
Status Completed
Phase N/A
First received January 20, 2010
Last updated March 18, 2015
Start date January 2010
Est. completion date January 2015

Study information
Verified date March 2015
Source CSL Behring
Contact n/a
Is FDA regulated No
Health authority Austria: EthikkommissionItaly: Ethics CommitteeGermany: Ethics CommissionFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéBelgium: Ethics CommitteeSpain: Ethics CommitteeSwitzerland: SwissmedicGreece: National Organization of MedicinesGreece: Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 78
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Male
Age group 14 Years to 35 Years
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
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 20 Vienna
Austria CSLB Study Site 21 Vienna
Austria CSLB Study Site 27 Vienna
Belgium CSLB Study Site 52 Edegem
Belgium CSLB Study Site 51 Leuven
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
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
Italy CSLB Study Site 72 Genova
Italy CSLB Study Site 71 Milan
Italy CSLB Study Site 74 Napoli
Italy CSLB Study Site 73 Palermo
Spain CSLB Study Site 98 Badajoz
Spain CSLB Study Site 95 Jaen
Spain CSLB Study Site 91 Valencia
Switzerland CSLB Study Site 35 St. Gallen
Switzerland CSLB Study Site 36 Zürich

Sponsors (1)
Lead Sponsor Collaborator
CSL Behring

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Italy,  Spain,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Health Related Quality of Life (HRQoL) baseline and every 12 months over 3 years No
Secondary Change in HRQoL due to pre-specified factors potentially affecting HRQoL in patients with hemophilia Duration of the study No
Secondary Change in HRQoL due to transitional life events Duration of the study No
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