Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIGGAM 10-06NCT02303093

Non-Interventional Study on the Tolerability and Efficacy of IVIG

An observational study of Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG, run by Octapharma at 38 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Non-Interventional Study on the Tolerability and Efficacy of octagam® 10% Read more about this study

Who is it for?: Any age
Conditions the study is for: Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG
What is being tested?: Octagam IVIG 5% or 10% and Panzyga
How many people: 344 participants
Where: 38 sitesin 5 countries
Study dates: 1 Aug 2011to 5 Jun 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Any patient who needs to be treated with a product of this class because of his/her medical condition and whom the treating physician decides to prescribe Octagam or panzyga regularly, may be included.

Who may be able to join

Any patient who needs to be treated with a product of this class because of his/her medical condition and whom the treating physician decides to prescribe Octagam or panzyga regularly, may be included.

Who cannot join

None

Trial locations and contacts

38 sites in 5 countries.

Country

City, postcode or hospital

38 sites in 5 countries

France17 sites

Octapharma Research Site
Argenteuil, 95107
Octapharma Research Site
Béziers, 34525
Octapharma Research Site
Bourges, 18020
Octapharma Research Location
Caen, 14033
Octapharma Research Site
Caen, 14033
Octapharma Research Site
La Rochelle, 17019
Octapharma Research Site
Marseille, 13285
Octapharma Research Location
Marseille, 13385
Octapharma Research Site
Marseille, 13385
Octapharma Research Center
Marseille, 13825
Octapharma Research Site
Montauban, 82013
Octapharma Research Site
Nantes, 44093
Octapharma Research Site
Nevers, 58033
Octapharma Research Site
Pessac, 33064
Octapharma Research Site
Pierre-Bénite, 69310
Octapharma Research Site
Rennes, 35033
Octapharma Research Site
Toulouse, 31300

Other trials in France

Austria6 sites

Octapharma Research Site
Gmunden, 17 4810
Octapharma Research Site
Graz, 22 8036
Octapharma Research Site
Klagenfurt, 35 9020
Octapharma Research Site
Oberndorf, 56 5110
Octapharma Research Site
Salzburg, 5020
Octapharma Research Site
Vienna, 1090

Other trials in Austria

Canada5 sites

Hamilton Health Sciences
Hamilton, Ontario, L8N3Z5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Spain5 sites

Octapharma Research Site
Barcelona, 08035
Octapharma Research Site
Madrid, 28040
Octapharma Research Location
Madrid, 28041
Octapharma Research Site
Madrid, 28041
Octapharma Research Site
Madrid, 28046

Other trials in Spain

United Kingdom5 sites

Octapharma Research Site
Leeds, LS97TF
Octapharma Research Site
London, E1 1BB
Octapharma Research Site
London, NW33QG
Octapharma Research Site
Plymouth, PL68DH
Octapharma Research Site
Stafford, ST16 3SA

Other trials in United Kingdom

About this study

Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%

Read the detailed description

A Non-Interventional Study on the Tolerability and Efficacy of Octagam 5% or 10% or panzyga. Patients with any indication (replacement and immonomodulation) as prescribed by the treating physician. Marketed Octagam 5% or 10% or panzyga will be used according to the investigator prescription; intravenous (iv) administration.The primary objective is to detect and evaluate adverse drug reactions (ADRs) occurring during or after the administration of Octagam or panzyga in any indication, age group or treatment regimen, where a causal relationship to the administration of Octagam or panzyga is suspected.

Conditions: Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG
Being tested: Octagam IVIG 5% or 10%, Panzyga

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Octagam IVIG 5% or 10%Biological
Octagam IVIG 5% or 10%
PanzygaBiological
Panzyga

Study groups in NCT02303093
Study group	Role	What they receive
Octagam		Patient receiving Octagam 5% or 10% IVIG Receives: Biological: Octagam IVIG 5% or 10%
Panzyga		Patient receiving panzyga Receives: Biological: Panzyga

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Drug Reactions
Number of patients with adverse drug reactions
Measured: up to one year

Secondary outcomes (1)

Infection Occurrence
Pool of PID/SID Patients: Influence of IVIG/SCIG Treatment. Frequency, intensity, and duration of infectious episodes assessed. At the last available assessment, the influence of study IVIG on the frequency, intensity, and duration of the infections.
Measured: Up to one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20115 Jun 2020

First posted27 Nov 2014 (estimated)
Study start1 Aug 2011
Primary completion5 Jun 2020
Study completion5 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIGStudies of the same condition, open and under way.
More trials run by OctapharmaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 344 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02303093
Sponsor's protocol ID: GAM 10-06
Acronym: GAM 10-06
Status last verified: Jun 2021
First submitted: 20 Nov 2014
Last updated: 29 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-Interventional Study on the Tolerability and Efficacy of IVIG
ClinicalTrials.gov ID: NCT02303093
Acronym / sponsor ID: GAM 10-06 / GAM 10-06
Conditions: Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG
Study type: Observational
Recruitment status: Completed
Enrolment: 344 participants (actual)
Lead sponsor: OctapharmaIndustry (pharma, biotech, devices)
Study start: 1 Aug 2011 (actual)
Primary completion: 5 Jun 2020 (actual)
Study completion: 5 Jun 2020 (actual)
First posted: 27 Nov 2014 (estimated)
Results: Posted 29 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Octagam	–	Biological: Octagam IVIG 5% or 10%Patient receiving Octagam 5% or 10% IVIG
Panzyga	–	Biological: PanzygaPatient receiving panzyga

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Any patient who needs to be treated with a product of this class because of his/her medical condition and whom the treating physician decides to prescribe Octagam or panzyga regularly, may be included.

Key inclusion criteria (1 listed)

Any patient who needs to be treated with a product of this class because of his/her medical condition and whom the treating physician decides to prescribe Octagam or panzyga regularly, may be included.

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Octagam IVIG 5% or 10%Octagam IVIG 5% or 10%	Biological	Octagam
PanzygaPanzyga	Biological	Panzyga

Primary outcome

Adverse Drug Reactions
Time frame: up to one year
Number of patients with adverse drug reactions

1 secondary outcome

Infection Occurrence
Time frame: Up to one year

Results and safety

Results posted to the registry on 29 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Patients	344	344

Primary outcome: Adverse Drug Reactions

Time frame: up to one year. Count of participants. Unit: Participants

Measure	Octagam 5% n = 139	Octagam 10% n = 183	Octagam 5% and Octagam 10%, While Under Octagam 5% n = 11	Octagam 5% and Octagam 10%, While Under Octagam 10% n = 11	Octagam 10% and Panzyga, While Under Octagam 10% n = 11	Octagam 10% and Panzyga, While Under Panzyga n = 11
Value	17	37	0	1	9	9

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Approximately 12 months, observational study. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Octagam 5%	3 of 139 (2.2%)	13 of 139 (9.4%)	1 of 139
Octagam 10%	1 of 183 (0.5%)	37 of 183 (20.2%)	0 of 183
Octagam 5% and Octagam 10%, While Under Octagam 5%	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Octagam 5% and Octagam 10%, While Under Octagam 10%	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11
Octagam 10% and Panzyga, While Under Octagam 10%	1 of 11 (9.1%)	9 of 11 (81.8%)	0 of 11
Octagam 10% and Panzyga, While Under Panzyga	0 of 11 (0%)	9 of 11 (81.8%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lidia Cosentino study director

Octapharma

38 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG, run by Octapharma at 38 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in France, Austria, Canada, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Drug Reactions (time frame: up to one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02303093.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.