Status:
COMPLETED
A Safety Study of GAMMAGARD LIQUID (GGL) in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Lead Sponsor:
Takeda
Collaborating Sponsors:
Baxalta Innovations GmbH, now part of Shire
RTI Health Solutions
Conditions:
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Eligibility:
All Genders
18+ years
Brief Summary
The main aim of this study is to evaluate the rates of adverse events of special interest (AESIs) (thrombotic events, acute kidney injury \[AKI\], and hemolytic events) among participants with CIDP in...
Eligibility Criteria
Inclusion
- Have a minimum of 6 months of continuous enrollment in the study database with medical and pharmacy coverage before the index date. Gaps in continuous enrollment less than or equal to (\<=) 31 days are permitted.
- Fulfill the Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) diagnosis algorithm on or before the index date using all available baseline data for each participant.
- Additionally, to be eligible for the Ig-naive (new-to-class) cohort, participants will be required to meet the following inclusion criterion:
- Be free of any previous recorded use of any Ig product at any point before IVIG initiation.
- To be eligible for the Ig-experienced (new-to-drug) cohort, participants will be required to meet the following inclusion criterion:
- Have any previous recorded use of an Ig product at any point before the index date.
Exclusion
- Having claims for greater than or equal to (\>=) 2 different IVIG products on the index date.
- Recorded diagnosis of any of the following conditions where Ig products are used for treatment on or before the index date
- Primary immunodeficiency disease (PID).
- Evidence of secondary immunodeficiency (SID), including hematological malignancy (e.g., diagnosis of multiple myeloma or chronic lymphocytic leukemia) or treatment with rituximab.
- Idiopathic thrombocytopenic purpura (ITP).
- Dermatomyositis or polymyositis.
- Systemic sclerosis/scleroderma.
- Myasthenia gravis.
Key Trial Info
Start Date :
May 27 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
6086 Patients enrolled
Trial Details
Trial ID
NCT05363358
Start Date
May 27 2022
End Date
December 1 2022
Last Update
May 1 2023
Active Locations (1)
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1
RTI Health Solutions
Durham, North Carolina, United States, 12194