Plain English Summary
Background and study aims
An antibody is a protein made by the immune system that recognises harmful substances in the body, such as bacteria and viruses, and neutralises them. Gammanorm® is a human immunoglobulin medicine that contains a number of antibodies and is given as an injection to treat people that have immune systems that produce few antibodies; these include patients with congenital or acquired antibody deficiencies. We want to find out more about the daily routine use of gammanorm® and get information about patient satisfaction and health-related quality of life during therapy.
Who can participate?
Patients of any age and gender that are treated with gammanorm®.
What does the study involve?
Doctors that have patients being treated with gammanorm® document, or record, information about those patients. This includes gathering data about how the patient takes their medicine, the disease they are suffering from, their age, gender, weight, any other medicine they are taking or any other illnesses that they have. No special investigations or procedures need to be done and it does not interfere with the patient's usual treatment as prescribed by the doctor. In order to get information about the health-related quality of life, patients are asked by their doctors to fill in a questionnaire at the beginning of the study and then every six months for up to 2 years.
What are the possible benefits and risks of participating?
The data will help to build up detailed knowledge about the subcutaneous route (that is, injection) of immunoglobulin treatment, especially regarding the patient's satisfaction and health-related quality of life. Gammanorm® is a registered product, the possible side-effects are described in the package insert.
Where is the study run from?
The trial takes place in about 30 study centres in Germany.
When is study starting and how long is it expected to run for?
June 2014 to May 2018
Who is funding the study?
Octapharma GmbH (Germany)
Who is the main contact?
Dr. Anette Debes
anette.debes@octapharma.de
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
GAN-04
Study information
Scientific title
Non-interventional study on the subcutaneous application of gammanorm®
Acronym
Study hypothesis
Home-based subcutaneous treatment with gammanorm® improves patient's satisfaction and quality of life.
Ethics approval
Not provided at the time of registration
Study design
Non-interventional, prospective, multi-centre, observational study
Primary study design
Observational
Secondary study design
Multi-centre
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Primary immunodeficiency syndromes/severe secondary hypogammaglobulinaemia
Intervention
Treatment with gammanorm in routine clinical use will be documented. This includes data about the patient's disease, age, gender, weight, concomitant medication or illness and information about the application. If available, laboratory data about the efficacy of treatment should also be documented. Information about quality of life will be documented at the beginning and every six months. Each patient can be documented for a maximum of 2 years. No special or additional investigations must be initiated for the purpose of this non-interventional study.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Information about the treatment with gammanorm® in home therapy and the health-related quality of life will collected by using CRFs and appropriate questionnaires (SF-36 and CHQ-PF50).
Secondary outcome measures
Efficacy of treatment will be measured by evaluating laboratory data, if available.
Overall trial start date
01/06/2014
Overall trial end date
31/05/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients of any gender and age, who receive treatment with gammanorm®
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
100
Participant exclusion criteria
Hypersensitivity to any of the components
Recruitment start date
01/06/2014
Recruitment end date
31/05/2018
Locations
Countries of recruitment
Germany
Trial participating centre
Elisabeth-Selbert-Str. 11
Langenfeld
40764
Germany
Funders
Funder type
Industry
Funder name
Octapharma GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list