- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02303093
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
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
-
-
-
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
-
-
-
-
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
-
-
-
-
-
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
-
-
-
-
-
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
-
-
-
-
-
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
|
Octagam IVIG 5% or 10%
|
Panzyga
Patient receiving 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
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.
Clinical Trials on Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG
-
University of Texas Southwestern Medical CenterMassachusetts General HospitalRecruitingDystonia | Dystonia; Idiopathic | Dystonia, Primary | Dystonia, Secondary | Dystonia, Familial | Dystonia Disorder | Dystonias, Sporadic | Dystonia; Orofacial | Dystonia Lenticularis | Dystonia, Paroxysmal | Dystonia 6 | Dystonia 5 | Dystonia 8 | Dystonia 9 | Dystonia 19 | Dystonia 10 | Dystonia 11 | Dystonia 20 | Dystonia 12 | Dystonia... and other conditionsUnited States
-
Wuhan UniversityPeking University; PfizerUnknownThe Primary Evaluation is the Change From Baseline at End of Study for CDSS Total Scores. | The Secondary Efficacy Evaluations Include: MADRS, PANSS Total Scores and Subscales and Responder Rate; CGI-S and CGI-I Scales. | Safety Evaluations Include: Laboratory Test Abnormalities; BARS... and other conditions
-
National Human Genome Research Institute (NHGRI)RecruitingMetabolic Disease | Purine-Pyrimidine Metabolism | AICDA, OMIM *605257, Immunodeficiency With Hyper-IgM, Type 2; HIGM2 | UNG, OMIM *191525, Hyper-IgM Syndrome 5 | NT5C3A<TAB>, OMIM *606224, Anemia, Hemolytic, Due to UMPH1 Deficiency | UMPS, OMIM *613891, Orotic Aciduria | DHODH, OMIM *126064,... and other conditionsUnited States
-
Centre Hospitalier Régional de la CitadelleSanofi; Takeda; University of Liege; Orchard Therapeutics; Centre Hospitalier Universitaire... and other collaboratorsRecruitingCongenital Adrenal Hyperplasia | Hemophilia A | Hemophilia B | Mucopolysaccharidosis I | Mucopolysaccharidosis II | Cystic Fibrosis | Alpha 1-Antitrypsin Deficiency | Sickle Cell Disease | Fanconi Anemia | Chronic Granulomatous Disease | Wilson Disease | Severe Congenital Neutropenia | Ornithine Transcarbamylase... and other conditionsBelgium
-
Roswell Park Cancer InstituteCompletedPrimary Myelofibrosis | Polycythemia Vera | Chronic Myelomonocytic Leukemia | Recurrent Adult Acute Myeloid Leukemia | Juvenile Myelomonocytic Leukemia | Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Adult Burkitt Lymphoma and other conditionsUnited States
-
Sanford HealthNational Ataxia Foundation; Beyond Batten Disease Foundation; Pitt Hopkins Research... and other collaboratorsRecruitingMitochondrial Diseases | Retinitis Pigmentosa | Myasthenia Gravis | Eosinophilic Gastroenteritis | Multiple System Atrophy | Leiomyosarcoma | Leukodystrophy | Anal Fistula | Spinocerebellar Ataxia Type 3 | Friedreich Ataxia | Kennedy Disease | Lyme Disease | Hemophagocytic Lymphohistiocytosis | Spinocerebellar Ataxia... and other conditionsUnited States, Australia
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedPrimary Myelofibrosis | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Chronic Myelomonocytic Leukemia | Recurrent Adult Acute Myeloid Leukemia | Juvenile Myelomonocytic Leukemia | Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal... and other conditionsUnited States
Clinical Trials on Octagam IVIG 5% or 10%
-
IMMUNOe Research CentersOctapharmaUnknownPediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections | Pediatric Acute-Onset Neuropsychiatric SyndromeUnited States
-
Sharp HealthCareUnknownCovid19 | SARS-CoV InfectionUnited States
-
OctapharmaCompletedAlzheimer's DiseaseUnited States
-
OctapharmaCompleted
-
Kedrion S.p.A.RecruitingPrimary Immunodeficiency DiseaseHungary, Italy, Slovakia, Portugal, Russian Federation
-
Kedrion S.p.A.CompletedPrimary Immunodeficiency DiseaseUnited States
-
RezoluteRecruitingCongenital HyperinsulinismBulgaria, Canada, Denmark, France, Georgia, Germany, Greece, Israel, Oman, Qatar, Saudi Arabia, Spain, Turkey, United Arab Emirates, United Kingdom, Vietnam
-
Kedrion S.p.A.CompletedPrimary Immunodeficiency | Hypogammaglobulinemia | Agammaglobulinemia | Antibody DeficiencyUnited States, Canada
-
Affiliated Hospital to Academy of Military Medical...UnknownRadiation Injuries, ExperimentalChina
-
Sutter HealthCompletedMild Cognitive ImpairmentUnited States