Condition category
Haematological Disorders
Date applied
30/05/2014
Date assigned
23/09/2014
Last edited
30/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Axel Jansink

ORCID ID

Contact details

Elisabeth-Selbert-Str. 11
Langenfeld
40764
Germany

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 measures

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

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

Sponsor information

Organisation

Octapharma GmbH (Germany)

Sponsor details

Elisabeth-Selbert-Str. 11
Langenfeld
40764
Germany

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes