Condition category
Haematological Disorders
Date applied
26/11/2008
Date assigned
03/12/2008
Last edited
03/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anette Debes

ORCID ID

Contact details

Elisabeth-Selbert-Str. 11
Langenfeld
40764
Germany
anette.debes@octapharma.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GAM10-05

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval

As the procedures during this observational study do not interfere with the patient's usual treatment and monitoring of treatment, this study is not regarded as a clinical study as defined by EU Directive 2001/20/EC. Therefore, approval by an Independent Ethical Committee is not required.

Study design

Non-interventional, prospective, multi-centre, observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

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

Primary or secondary immunodeficiencies, immunomodulation in autoimmune diseases

Intervention

Treatment with 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.

The number of treatments with Octagam® 10% for each patient cannot be defined due to the different indications where it is used. Therefore some patients will be treated and observed for a few weeks and others for several months or years. For this reason, there are no specified timepoints for the outcomes of this trial.

Intervention type

Drug

Phase

Not Specified

Drug names

Octagam® 10%

Primary outcome measures

To observe the tolerability of Octagam® 10% in different indication groups in routine clinical practice.

Secondary outcome measures

Data about the efficacy of Octagam® 10%.

Overall trial start date

15/09/2008

Overall trial end date

14/09/2013

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Participant exclusion criteria

Patients with known contraindications to Octagam® 10%

Recruitment start date

15/09/2008

Recruitment end date

14/09/2013

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
info@octapharma.de

Sponsor type

Industry

Website

http://www.octapharma.de/

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