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Quality of Life Study of Helixate NexGen

NCT ID: NCT01053715

Last Updated: 2015-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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CSL Behring

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Klamroth, MD

Role: PRINCIPAL_INVESTIGATOR

Hämophiliezentrum, Vivantes-Klinikum im Friedrichshain Zentrum für Gefäßmedizin, Berlin

Alessandro Gringeri, MD

Role: PRINCIPAL_INVESTIGATOR

I.R.C.C.S. Fondazione Ospedale Maggiore Policlinico, Milan

Locations

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CSLB Study Site 22

Graz, , Austria

Site Status

CSLB Study Site 26

Grieskirchen, , Austria

Site Status

CSLB Study Site 24

Innsbruck, , Austria

Site Status

CSLB Study Site 29

Klagenfurt, , Austria

Site Status

CSLB Study Site 23

Linz, , Austria

Site Status

CSLB Study Site 25

Sankt Pölten, , Austria

Site Status

CSLB Study Site 20

Vienna, , Austria

Site Status

CSLB Study Site 21

Vienna, , Austria

Site Status

CSLB Study Site 27

Vienna, , Austria

Site Status

CSLB Study Site 52

Edegem, , Belgium

Site Status

CSLB Study Site 51

Leuven, , Belgium

Site Status

CSLB Study Site 65

Amiens, , France

Site Status

CSLB Study Site 68

Poitiers, , France

Site Status

CSLB Study Site 60

Rouen, , France

Site Status

CSLB Study Site 64

Strasbourg, , France

Site Status

CSLB Study Site 66

Valence, , France

Site Status

CSLB Study Site 1

Berlin, , Germany

Site Status

CSLB Study Site 3

Bonn, , Germany

Site Status

CSLB Study Site 2

Bremen, , Germany

Site Status

CSLB Study Site 6

Delmenhorst, , Germany

Site Status

CSLB Study Site 7

Göttingen, , Germany

Site Status

CSLB Study Site 4

München, , Germany

Site Status

CSLB Study Site 72

Genova, , Italy

Site Status

CSLB Study Site 71

Milan, , Italy

Site Status

CSLB Study Site 74

Napoli, , Italy

Site Status

CSLB Study Site 73

Palermo, , Italy

Site Status

CSLB Study Site 98

Badajoz, , Spain

Site Status

CSLB Study Site 95

Jaén, , Spain

Site Status

CSLB Study Site 91

Valencia, , Spain

Site Status

CSLB Study Site 35

Sankt Gallen, , Switzerland

Site Status

CSLB Study Site 36

Zurich, , Switzerland

Site Status

Countries

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Austria Belgium France Germany Italy Spain Switzerland

Other Identifiers

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1501

Identifier Type: OTHER

Identifier Source: secondary_id

CE1250_5002_EU

Identifier Type: -

Identifier Source: org_study_id

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