Condition category
Skin and Connective Tissue Diseases
Date applied
15/11/2013
Date assigned
19/11/2013
Last edited
16/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Octagam® 5% and Octagam® 10% are solutions that contain human immunoglobulins (antibodies) and are given through the vein (intravenously). They are used for the treatment of congenital or acquired antibody deficiency diseases, immune modulation or in bone marrow transplantation. This study aims to expand our knowledge and experience in the safe use of these medicines.

Who can participate?
Patients who receive treatment with Octagam® 5% or Octagam® 10% can participate in the study.

What does the study involve?
This study does not have any procedures (interventions). Only information about treatment with Octagam® 5% and Octagam® 10% in routine clinical practice will be collected. The treatment with Octagam® 5% and Octagam® 10% will be the same as if they were prescribed outside of the study.

What are the possible benefits and risks of participating?
This is a safety study and all collected information about the observed medicines will make an important scientific contribution in keeping or even improving the high levels of tolerability and safety of Octagam® 5% and Octagam® 10%. These are registered products and the side effects are described in the package insert.

Where is the study run from?
About 150 study centres from all over Germany are participating in this study. Recruitment of participating physicians is still ongoing.

When is the study starting and how long is it expected to run for?
January 2014 to December 2017

Who is funding the study?
Octapharma GmbH (Germany).

Who is the main contact?
Mr Christian Lietz
christian.lietz@octapharma.de

Trial website

Contact information

Type

Scientific

Primary contact

Mr Christian Lietz

ORCID ID

Contact details

Elisabeth-Selbert-Strasse 11
Langenfeld
40764
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GAM-33

Study information

Scientific title

Non-interventional safety study on the tolerability and safety of Octagam® 5% and Octagam® 10%

Acronym

Study hypothesis

Octagam® 5 % and Octagam® 10% are well tolerated in the treatment of primary or secondary immunodeficiencies or in the immunomodulation of autoimmune diseases, in routine clinical use.

Ethics approval

An approval by an independent Ethical Committee will be applied for.

Study design

Non-interventional prospective multi-centre safety study

Primary study design

Observational

Secondary study design

Multi-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

As specified in the SPC

Intervention

Treatment with Octagam® 5% and Octagam® 10% will be documented. This includes data about the patient's disease, age, gender, weight, concomitant medication or illness. For each application, the date and duration of infusion, dose, batch number(s) and the absence or occurrence of an adverse drug reaction (ADR) will be recorded. In case of an ADR, additional detailed information about the reaction will be recorded. If available, laboratory data about the efficacy of treatment should also be documented. No investigations must be initiated for the purpose of this non-interventional trial.

Intervention type

Drug

Phase

Not Applicable

Drug names

Octagam® 5% and Octagam® 10%

Primary outcome measures

The physician will have to fill out CRFs and send them back in a bunch of six subsequent documented treatments including one form which describes the progress of the treatment over this period. The individual observation period is not limited.

Secondary outcome measures

Quality of life will be evaluated by using the SF-36 health survey

Overall trial start date

01/01/2014

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Patients of any age and gender, who receive treatment with Octagam® 5% or Octagam® 10%

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2000

Participant exclusion criteria

Patients with known contraindications as specified in the Summary of Product Characteristics (SPC)

Recruitment start date

01/01/2014

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Germany

Trial participating centre

Elisabeth-Selbert-Strasse 11
Langenfeld
40764
Germany

Sponsor information

Organisation

Octapharma GmbH (Germany)

Sponsor details

Elisabeth-Selbert-Strasse 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

On 16/02/2016 the overall trial end date was changed from 31/12/2015 to 31/12/2017.