Condition category
Haematological Disorders
Date applied
01/09/2011
Date assigned
25/10/2011
Last edited
01/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims?
Several kinds of illnesses (autoimmune diseases and immune deficient conditions) are treated with Octagam. Octagam is a solution that contains human antibodies, also called immunoglobulins. In this study the data about the treatment with Octagam will be collected to analyse how often and which side effects might occur when treated with Octagam in regular praxis as prescribed by your doctor.

Who can participate?
Only the doctor can decide which disease can be treated with Octagam. People of any age and any gender are welcome to participate.

What does the study involve?
The study collects only data and therefore the doctor might ask you some questions regarding previous diseases or treatments. There will be no special investigations or procedures due to the study. The treatment with Octagam will be regular as prescribed by your doctor without the study.

What are the possible benefits and risks of participating?
All information collected in the course of the treatment with Octagam may make an important scientific contribution, in particular to other patients suffering from the same or similar conditions that may also be treated with Octagam. Octagam is a registered product, the side effects are described in the package insert.

Where is the study run from?
About 1000 patients will participate in this study, which will be performed in several countries around the world (e.g. Austria, France, UK, Brazil, and other). In the USA there will be a related study.

When is study starting and how long is it expected to run for?
The study is planned to start in September 2011. The overall study duration will be approximately 3 years.

Who is funding the study?
A Swiss company called Octapharma, who is producing Octagam, is organising and funding this study.

Who is the main contact?
Dr. Daniel Svorc and Dr. Stefan Wietek
daniel.svorc@octapharma.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Franz Fazekas

ORCID ID

Contact details

Auenbruggerplatz 22
Graz
8036
Austria

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GAM10-06

Study information

Scientific title

A non-interventional study on the tolerability of Octagam® 5% and Octagam® 10%

Acronym

GammaTrack

Study hypothesis

Re-establish the tolerability profile of Octagam® seen over the last 15 years before the suspension of the marketing authorisations for Octagam® (human normal immunoglobulin 5% and 10%) by the European Medicines Agency.

Ethics approval

Ethics Committee of Medical University Graz, Austria, 25/07/2011 ref: 23-474 ex 10/11

Study design

Prospective uncontrolled multi-centre multi-national non-interventional study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

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

Condition

Any indication, age, or treatment regimen in which Octagam is prescribed

Intervention

The individual observation period for one patient is not limited, PID patients should be observed for a minimum of 10 months, if possible.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Incidence of adverse drug reactions (ADRs)

Secondary outcome measures

Efficacy of treatment

Overall trial start date

01/09/2011

Overall trial end date

01/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

All patients treated with Octagam at a participitating site.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1000

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/09/2011

Recruitment end date

01/06/2014

Locations

Countries of recruitment

Austria, Brazil, France, Russian Federation, United Kingdom

Trial participating centre

Auenbruggerplatz 22
Graz
8036
Austria

Sponsor information

Organisation

Octapharma AG (Switzerland)

Sponsor details

c/o Dr Daniel Svorc
Seidenstrasse 2
Lachen
8853
Switzerland

Sponsor type

Industry

Website

http://www.octapharma.com/en.html

Funders

Funder type

Industry

Funder name

Octapharma AG (Switzerland)

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

01/12/2016: No publications found in PubMed, verifying study status with principal investigator.