ISRCTN ISRCTN66955626
DOI https://doi.org/10.1186/ISRCTN66955626
Secondary identifying numbers GAN-04
Submission date
30/05/2014
Registration date
23/09/2014
Last edited
30/09/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Axel Jansink
Scientific

Elisabeth-Selbert-Str. 11
Langenfeld
40764
Germany

Study information

Study designNon-interventional, prospective, multi-centre, observational study
Primary study designObservational
Secondary study designMulti-centre
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet.
Scientific titleNon-interventional study on the subcutaneous application of gammanorm®
Study objectivesHome-based subcutaneous treatment with gammanorm® improves patient's satisfaction and quality of life.
Ethics approval(s)Not provided at the time of registration
Health condition(s) or problem(s) studiedPrimary immunodeficiency syndromes/severe secondary hypogammaglobulinaemia
InterventionTreatment 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 typeOther
Primary outcome measureInformation 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 measuresEfficacy of treatment will be measured by evaluating laboratory data, if available.
Overall study start date01/06/2014
Completion date31/05/2018

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants100
Key inclusion criteriaPatients of any gender and age, who receive treatment with gammanorm®
Key exclusion criteriaHypersensitivity to any of the components
Date of first enrolment01/06/2014
Date of final enrolment31/05/2018

Locations

Countries of recruitment

  • Germany

Study participating centre

Elisabeth-Selbert-Str. 11
Langenfeld
40764
Germany

Sponsor information

Octapharma GmbH (Germany)
Industry

Elisabeth-Selbert-Str. 11
Langenfeld
40764
Germany

ROR logo "ROR" https://ror.org/002k5fe57

Funders

Funder type

Industry

Octapharma GmbH (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan