Quality of Life Study of Helixate NexGen

March 18, 2015 updated by: CSL Behring

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • CSLB Study Site 22
      • Grieskirchen, Austria
        • CSLB Study Site 26
      • Innsbruck, Austria
        • CSLB Study Site 24
      • Klagenfurt, Austria
        • CSLB Study Site 29
      • Linz, Austria
        • CSLB Study Site 23
      • St. Pölten, Austria
        • CSLB Study Site 25
      • Vienna, Austria
        • CSLB Study Site 20
      • Vienna, Austria
        • CSLB Study Site 21
      • Vienna, Austria
        • CSLB Study Site 27
  • Belgium
      • Edegem, Belgium
        • CSLB Study Site 52
      • Leuven, Belgium
        • CSLB Study Site 51
  • France
      • Amiens, France
        • CSLB Study Site 65
      • Poitiers Cedex, France
        • CSLB Study Site 68
      • Rouen, France
        • CSLB Study Site 60
      • Strasbourg, France
        • CSLB Study Site 64
      • Valence, France
        • CSLB Study Site 66
  • Germany
      • Berlin, Germany
        • CSLB Study Site 1
      • Bonn, Germany
        • CSLB Study Site 3
      • Bremen, Germany
        • CSLB Study Site 2
      • Delmenhorst, Germany
        • CSLB Study Site 6
      • Göttingen, Germany
        • CSLB Study Site 7
      • München, Germany
        • CSLB Study Site 4
  • Italy
      • Genova, Italy
        • CSLB Study Site 72
      • Milan, Italy
        • CSLB Study Site 71
      • Napoli, Italy
        • CSLB Study Site 74
      • Palermo, Italy
        • CSLB Study Site 73
  • Spain
      • Badajoz, Spain
        • CSLB Study Site 98
      • Jaen, Spain
        • CSLB Study Site 95
      • Valencia, Spain
        • CSLB Study Site 91
  • Switzerland
      • St. Gallen, Switzerland
        • CSLB Study Site 35
      • Zürich, Switzerland
        • CSLB Study Site 36

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 35 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Health Related Quality of Life (HRQoL)
Time Frame: baseline and every 12 months over 3 years
baseline and every 12 months over 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in HRQoL due to pre-specified factors potentially affecting HRQoL in patients with hemophilia
Time Frame: Duration of the study
Duration of the study
Change in HRQoL due to transitional life events
Time Frame: Duration of the study
Duration of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CSL Behring

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CE1250_5002_EU
  • 1501 (CSL Behring)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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