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Quality of Life Study of Helixate NexGen

Information source: CSL Behring
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemophilia A

Phase: N/A

Status: Completed

Sponsored by: CSL Behring

Official(s) and/or principal investigator(s):
Robert Klamroth, MD, Principal Investigator, Affiliation: Hämophiliezentrum, Vivantes-Klinikum im Friedrichshain Zentrum für Gefäßmedizin, Berlin
Alessandro Gringeri, MD, Principal Investigator, Affiliation: I.R.C.C.S. Fondazione Ospedale Maggiore Policlinico, Milan

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Health Related Quality of Life (HRQoL)

Secondary outcome:

Change in HRQoL due to pre-specified factors potentially affecting HRQoL in patients with hemophilia

Change in HRQoL due to transitional life events

Eligibility

Minimum age: 14 Years. Maximum age: 35 Years. Gender(s): Male.

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

Locations and Contacts

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, Austria

CSLB Study Site 52, Edegem, Belgium

CSLB Study Site 51, Leuven, Belgium

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

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

CSLB Study Site 72, Genova, Italy

CSLB Study Site 71, Milan, Italy

CSLB Study Site 74, Napoli, Italy

CSLB Study Site 73, Palermo, Italy

CSLB Study Site 98, Badajoz, Spain

CSLB Study Site 95, Jaen, Spain

CSLB Study Site 91, Valencia, Spain

CSLB Study Site 35, St. Gallen, Switzerland

CSLB Study Site 36, Zürich, Switzerland

Additional Information

Click here to request more information about this study

Starting date: January 2010
Last updated: March 18, 2015

Page last updated: August 23, 2015

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