Non-Interventional Study on the Tolerability and Efficacy of IVIG (GAM 10-06)

June 5, 2021 updated by: Octapharma
Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

344

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Gmunden, Austria, 17 4810
        • Octapharma Research Site
      • Graz, Austria, 22 8036
        • Octapharma Research Site
      • Klagenfurt, Austria, 35 9020
        • Octapharma Research Site
      • Oberndorf, Austria, 56 5110
        • Octapharma Research Site
      • Salzburg, Austria, 5020
        • Octapharma Research Site
      • Wien, Austria, 1090
        • Octapharma Research Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8N3Z5
        • Hamilton Health Sciences
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
  • France
      • Argenteuil, France, 95107
        • Octapharma Research Site
      • Bourges, France, 18020
        • Octapharma Research Site
      • Béziers, France, 34525
        • Octapharma Research Site
      • Caen, France, 14033
        • Octapharma Research Location
      • Caen, France, 14033
        • Octapharma Research Site
      • La Rochelle, France, 17019
        • Octapharma Research Site
      • Marseille, France, 13285
        • Octapharma Research Site
      • Marseille, France, 13385
        • Octapharma Research Location
      • Marseille, France, 13385
        • Octapharma Research Site
      • Marseille, France, 13825
        • Octapharma Research Center
      • Montauban, France, 82013
        • Octapharma Research Site
      • Nantes, France, 44093
        • Octapharma Research Site
      • Nevers, France, 58033
        • Octapharma Research Site
      • Pessac, France, 33064
        • Octapharma Research Site
      • Pierre-Bénite, France, 69310
        • Octapharma Research Site
      • Rennes, France, 35033
        • Octapharma Research Site
      • Toulouse, France, 31300
        • Octapharma Research Site
  • Spain
      • Barcelona, Spain, 08035
        • Octapharma Research Site
      • Madrid, Spain, 28040
        • Octapharma Research Site
      • Madrid, Spain, 28041
        • Octapharma Research Location
      • Madrid, Spain, 28041
        • Octapharma Research Site
      • Madrid, Spain, 28046
        • Octapharma Research Site
  • United Kingdom
      • Leeds, United Kingdom, LS97TF
        • Octapharma Research Site
      • London, United Kingdom, E1 1BB
        • Octapharma Research Site
      • London, United Kingdom, NW33QG
        • Octapharma Research Site
      • Plymouth, United Kingdom, PL68DH
        • Octapharma Research Site
      • Stafford, United Kingdom, ST16 3SA
        • Octapharma Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Octagam
Patient receiving Octagam 5% or 10% IVIG
Biological: Octagam IVIG 5% or 10%
Octagam IVIG 5% or 10%
Panzyga
Patient receiving panzyga
Biological: Panzyga
Panzyga

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Drug Reactions
Time Frame: up to one year
Number of patients with adverse drug reactions
up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection Occurrence
Time Frame: Up to one year
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.
Up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Octapharma

Investigators

  • Study Director: Lidia Cosentino, Octapharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2011

Primary Completion (Actual)

June 5, 2020

Study Completion (Actual)

June 5, 2020

Study Registration Dates

First Submitted

November 20, 2014

First Submitted That Met QC Criteria

November 24, 2014

First Posted (Estimate)

November 27, 2014

Study Record Updates

Last Update Posted (Actual)

June 29, 2021

Last Update Submitted That Met QC Criteria

June 5, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAM 10-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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