|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
30 March 2015 |
|
Main ID: |
NCT01053715 |
|
Date of registration:
|
20/01/2010 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Quality of Life Study of Helixate NexGen
|
|
Scientific 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 |
|
Date of first enrolment:
|
January 2010 |
|
Target sample size:
|
78 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01053715 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Cohort, Time Perspective: Prospective
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Austria
|
Belgium
|
France
|
Germany
|
Italy
|
Spain
|
Switzerland
| |
|
Contacts
|
|
Name:
|
Robert Klamroth, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hämophiliezentrum, Vivantes-Klinikum im Friedrichshain Zentrum für Gefäßmedizin, Berlin |
|
|
Name:
|
Alessandro Gringeri, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
I.R.C.C.S. Fondazione Ospedale Maggiore Policlinico, Milan |
| |
|
Key inclusion & exclusion 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
Age minimum:
14 Years
Age maximum:
35 Years
Gender:
Male
|
|
Health Condition(s) or Problem(s) studied
|
|
Hemophilia A
|
|
Primary Outcome(s)
|
|
Health Related Quality of Life (HRQoL)
[Time Frame: baseline and every 12 months over 3 years]
|
|
Secondary Outcome(s)
|
|
Change in HRQoL due to transitional life events
[Time Frame: Duration of the study]
|
|
Change in HRQoL due to pre-specified factors potentially affecting HRQoL in patients with hemophilia
[Time Frame: Duration of the study]
|
|
Secondary ID(s)
|
|
CE1250_5002_EU
|
|
1501
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|