MedDataX Logo

Non-Interventional Study on the Tolerability and Efficacy of IVIG

NCT ID: NCT02303093

Last Updated: 2021-06-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

344 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-01

Study Completion Date

2020-06-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy, Safety and Kinetics Study of Octagam 10% in Primary Immunodeficiency Diseases

NCT00811174

Immunologic Deficiency Syndromes
TERMINATED PHASE3

The Benefit of 5% IVIG for Patients With Primary Immunodeficiency Disorders Who Experience Adverse Events on 10% IVIG Preparations

NCT03339778

Primary Immunodeficiency
COMPLETED

Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)

NCT01581593

Primary Immunodeficiency Agammaglobulinemia Hypogammaglobulinemia +1 more
COMPLETED PHASE3

Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections

NCT07220915

Hypogammaglobulinemia Autoimmune Conditions Rheumatic Conditions +1 more
NOT_YET_RECRUITING PHASE3

Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients

NCT03961009

Primary Immunodeficiency Disease
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Octagam

Patient receiving Octagam 5% or 10% IVIG

Octagam IVIG 5% or 10%

Intervention Type BIOLOGICAL

Octagam IVIG 5% or 10%

Panzyga

Patient receiving panzyga

Panzyga

Intervention Type BIOLOGICAL

Panzyga

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Octagam IVIG 5% or 10%

Octagam IVIG 5% or 10%

Intervention Type BIOLOGICAL

Panzyga

Panzyga

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Octapharma

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lidia Cosentino

Role: STUDY_DIRECTOR

Octapharma

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Octapharma Research Site

Gmunden, , Austria

Site Status

Octapharma Research Site

Graz, , Austria

Site Status

Octapharma Research Site

Klagenfurt, , Austria

Site Status

Octapharma Research Site

Oberndorf, , Austria

Site Status

Octapharma Research Site

Salzburg, , Austria

Site Status

Octapharma Research Site

Vienna, , Austria

Site Status

St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

Health Sciences Centre

Winnipeg, Manitoba, Canada

Site Status

Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Octapharma Research Site

Argenteuil, , France

Site Status

Octapharma Research Site

Béziers, , France

Site Status

Octapharma Research Site

Bourges, , France

Site Status

Octapharma Research Location

Caen, , France

Site Status

Octapharma Research Site

Caen, , France

Site Status

Octapharma Research Site

La Rochelle, , France

Site Status

Octapharma Research Site

Marseille, , France

Site Status

Octapharma Research Location

Marseille, , France

Site Status

Octapharma Research Site

Marseille, , France

Site Status

Octapharma Research Center

Marseille, , France

Site Status

Octapharma Research Site

Montauban, , France

Site Status

Octapharma Research Site

Nantes, , France

Site Status

Octapharma Research Site

Nevers, , France

Site Status

Octapharma Research Site

Pessac, , France

Site Status

Octapharma Research Site

Pierre-Bénite, , France

Site Status

Octapharma Research Site

Rennes, , France

Site Status

Octapharma Research Site

Toulouse, , France

Site Status

Octapharma Research Site

Barcelona, , Spain

Site Status

Octapharma Research Site

Madrid, , Spain

Site Status

Octapharma Research Location

Madrid, , Spain

Site Status

Octapharma Research Site

Madrid, , Spain

Site Status

Octapharma Research Site

Madrid, , Spain

Site Status

Octapharma Research Site

Leeds, , United Kingdom

Site Status

Octapharma Research Site

London, , United Kingdom

Site Status

Octapharma Research Site

London, , United Kingdom

Site Status

Octapharma Research Site

Plymouth, , United Kingdom

Site Status

Octapharma Research Site

Stafford, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria Canada France Spain United Kingdom

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GAM 10-06

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Immune Globulin Subcutaenous (Human), 20%
NCT01412385 COMPLETED PHASE2/PHASE3
Pharmacokinetics and Safety of IVIG Nanogam 100 mg/ml
NCT01985373 COMPLETED PHASE3
Study to Investigate Efficacy, Safety and Pharmacokinetics of BT595 in Subjects With PID
NCT02810444 COMPLETED PHASE3
Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects
NCT03116347 COMPLETED PHASE4
Phase 2/3 Study of IGSC, 20% in PIDD
NCT01218438 COMPLETED PHASE2/PHASE3
Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD
NCT01485796 COMPLETED PHASE2/PHASE3
A Multicenter Phase 2 Single-arm Proof-of-concept Trial Assessing the Efficacy and Safety of Obinutuzumab in the Treatment of Non-infectious Active Cryoglobulinemia Vasculitis Refractory or Intolerant to Rituximab
NCT07268521 NOT_YET_RECRUITING PHASE2
Tolerance and Patients' Satisfaction With IGHy
NCT03668288 UNKNOWN
Tocilizumab for the Treatment of Behcet's Syndrome
NCT01693653 TERMINATED PHASE2
Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID
NCT01175213 COMPLETED PHASE3
Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects
NCT00634569 COMPLETED PHASE4
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants With IgG4-RD
NCT07222553 NOT_YET_RECRUITING PHASE2
Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency
NCT02783482 COMPLETED PHASE3
An Open-label, Nonrandomized Study to Evaluate the Safety and Immunogenicity of Raxibacumab With Reinjection
NCT02016963 COMPLETED PHASE2/PHASE3
A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam®
NCT02247141 COMPLETED PHASE3
Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases
NCT03939533 COMPLETED PHASE3
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pozelimab in Combination With Cemdisiran in Healthy Adult Volunteers
NCT04601844 COMPLETED PHASE1
Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) Subjects
NCT00546871 COMPLETED PHASE2/PHASE3
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects
NCT01922336 COMPLETED PHASE1
Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy
NCT00419341 COMPLETED PHASE3
A Retrospective Cohort Study of Infusion Reactions Due to Vectibix
NCT01156090 COMPLETED
Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously
NCT00782106 COMPLETED PHASE1/PHASE2
Tocilizumab for Treatment of Steroid Refractory Acute Graft-versus-Host Disease
NCT01475162 TERMINATED PHASE1/PHASE2
Leniolisib for Immune Dysregulation in PIDs
NCT06549114 RECRUITING PHASE2
A Trial to Learn if Single Ascending Intravenous (IV) Doses of REGN7508 Are Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants
NCT05603195 COMPLETED PHASE1