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

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ClinicalTrials.gov Identifier: NCT02303093
Recruitment Status : Recruiting
First Posted : November 27, 2014
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Octapharma

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

Condition or disease Intervention/treatment
Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG Biological: Octagam IVIG 5% or 10% Biological: Panzyga

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Study on the Tolerability and Efficacy of IVIG
Actual Study Start Date : August 1, 2011
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Rhophylac

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




Primary Outcome Measures :
  1. Adverse Drug Reactions [ Time Frame: up to one year ]

Secondary Outcome Measures :
  1. Rate of Infection Occurrence [ Time Frame: Up to one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303093


Contacts
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Contact: Mikaela Grupp 8663371868 ctgov@clinicalresearchmgt.com

  Show 38 Study Locations
Sponsors and Collaborators
Octapharma
Investigators
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Study Director: Lidia Cosentino Octapharma

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Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT02303093     History of Changes
Other Study ID Numbers: GAM 10-06
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs