Quality of Life Study of Helixate NexGen
This study is ongoing, but not recruiting participants.
Sponsor:
CSL Behring
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT01053715
First received: January 20, 2010
Last updated: June 13, 2013
Last verified: June 2013
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Purpose
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.
| Condition |
|---|
|
Hemophilia A |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
hemophilia
MedlinePlus related topics:
Hemophilia
U.S. FDA Resources
Further study details as provided by CSL Behring:
Primary Outcome Measures:
- Health Related Quality of Life (HRQoL) [ Time Frame: baseline and every 12 months over 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 14 Years to 35 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with a diagnosis of moderate or severe Hemophilia A using Helixate NexGen identified by selected European hemophilia treatment centers.
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053715
Locations
| 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 27 | |
| Vienna, Austria | |
| CSLB Study Site 21 | |
| Vienna, Austria | |
| CSLB Study Site 20 | |
| Vienna, Austria | |
| Belgium | |
| CSLB Study Site 52 | |
| Edegem, Belgium | |
| CSLB Study Site 51 | |
| Leuven, Belgium | |
| France | |
| CSLB Study Site 65 | |
| Amiens, France | |
| CSLB Study Site 63 | |
| Dijon, 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 | |
| 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, Germany | |
| Italy | |
| CSLB Study Site 72 | |
| Genova, Italy | |
| CSLB Study Site 71 | |
| Milan, Italy | |
| CSLB Study Site 74 | |
| Napoli, Italy | |
| CSLB Study Site 73 | |
| Palermo, Italy | |
| Spain | |
| CSLB Study Site 98 | |
| Badajoz, Spain | |
| CSLB Study Site 95 | |
| Jaen, Spain | |
| CSLB Study Site 91 | |
| Valencia, Spain | |
| Switzerland | |
| CSLB Study Site 35 | |
| St. Gallen, Switzerland | |
| CSLB Study Site 36 | |
| Zürich, Switzerland | |
Sponsors and Collaborators
CSL Behring
Investigators
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | CSL Behring |
| ClinicalTrials.gov Identifier: | NCT01053715 History of Changes |
| Other Study ID Numbers: | CE1250_5002_EU, 1501 |
| Study First Received: | January 20, 2010 |
| Last Updated: | June 13, 2013 |
| Health Authority: | Austria: Ethikkommission Italy: Ethics Committee Germany: Ethics Commission France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé Belgium: Ethics Committee Spain: Ethics Committee Switzerland: Swissmedic Greece: National Organization of Medicines Greece: Ethics Committee |
Keywords provided by CSL Behring:
|
Hemophilia Quality of Life |
Additional relevant MeSH terms:
|
Hemophilia A Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases Coagulation Protein Disorders Hemorrhagic Disorders |
Genetic Diseases, Inborn Factor VIII Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013