Condition category
Haematological Disorders
Date applied
18/09/2012
Date assigned
15/10/2012
Last edited
15/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
The study will assess if Octagam 5% prevents serious bacterial infections.

Who can participate?
Patients aged between 18 and 75 years with immunodeficiency.

What does the study involve?
The patients will receive an examination at the start of the study and then receive five or six infusions of Octagam 5% over a period of up to 20 weeks. Participants will be asked to give a small amount of blood for assessment .

What are the possible benefits and risks of participating?
Patients’ health condition will be assessed very thoroughly and in shorter intervals than normal. There are no known risks of participating.

Where is the study run from?
Octapharma AG in Switzerland – a pharmaceutical company producing and selling products developed from blood plasma.

When is study starting and how long is it expected to run for?
Study is starting in June 2012 and expected end is in October 2013

Who is funding the study?
Octapharma AG, Switzerland

Who is the main contact?
Dr Eva Turpel-Kantor

Trial website

Contact information

Type

Scientific

Primary contact

Dr Eva Turpel Kantor

ORCID ID

Contact details

Octapharma
Vienna
1100
Austria

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GAMr-29

Study information

Scientific title

Prospective, open-label, non-controlled, multicenter, phase III clinical study to evaluate the pharmacokinetics, safety and efficacy of Octagam 5% in patients with Primary Immunodeficiency Diseases

Acronym

GAMr 29

Study hypothesis

The pharmacokinetic of Octagam 5% ("double-processed" Octagam) and efficacy in preventing serious bacterial infections is as to be expected for a compound of this class.

Ethics approval

Polish Ministry of Health, 24 September 2012 ref: MZ–OKB-078-262-1/EO

Study design

Prospective open-label non-controlled multicenter phase III study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

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 Immunodeficiency diseases (PID)

Intervention

Two multiple dose intravenous Octagam 5% regimens (every 3 weeks or every 4 weeks, continuing the patient’s pre-study infusion interval) for 6 or 5 Octagam infusions for patients on a 3-week or 4-week schedule, respectively .
The investigational medicinal product (IMP) name is Octagam 5%, a human immunoglobulin (Ig) solution with 5% protein content for intravenous administration.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

The primary endpoint is the PK profile of Octagam with respect to total IgG, IgG subclasses

Secondary outcome measures

The following parameters will be used in the safety and tolerability assessment of the treatment:
1. Vital signs
2. Physical examination
3. AEs
4. Laboratory parameters

Overall trial start date

15/07/2012

Overall trial end date

15/07/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age between 18 years and 75 years
2. Primary immunodeficiency syndromes with significant component hypogamma-globulinaemia or antibody deficiency
3. Previously treated with a commercial IVIG every 21–28 days for at least 6 infusion intervals at a constant dose between 200 and 800 mg/kg body weight
4. Availability of the IgG trough levels of the 2 previous infusions before enrolment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

23

Participant exclusion criteria

1. Acute infection
2. Known history of adverse reactions to IgA in other products
3. Exposure to blood or any blood product, other than commercially available IVIG, within the past 3 months prior to enrolment
4. Congestive heart failure NYHA class III or IV
5. Non-controlled arterial hypertension
6. History of deep vein thrombosis
7. Known HIV, HCV, or HBV infection

Recruitment start date

15/07/2012

Recruitment end date

15/07/2013

Locations

Countries of recruitment

Czech Republic

Trial participating centre

Octapharma
Vienna
1100
Austria

Sponsor information

Organisation

Octapharma (Switzerland)

Sponsor details

Oberlaaerstrasse 235
Vienna
1100
Austria

Sponsor type

Industry

Website

http://www.octapharma.com/

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