A Safety Study of GAMMAGARD LIQUID (GGL) in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Completed

• Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

• Registration Number: NCT05363358
• Lead Sponsor: Takeda

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 initiating GGL compared with rates among participants with CIDP initiating comparator intravenous immunoglobulin (IVIG) products.

No study medicines will be provided to participants in this study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-02
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-05
• Study Start: 2022-05-27
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6086

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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

  1. Primary immunodeficiency disease (PID).
  2. Evidence of secondary immunodeficiency (SID), including hematological malignancy (e.g., diagnosis of multiple myeloma or chronic lymphocytic leukemia) or treatment with rituximab.
  3. Idiopathic thrombocytopenic purpura (ITP).
  4. Dermatomyositis or polymyositis.
  5. Systemic sclerosis/scleroderma.
  6. Myasthenia gravis.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Thrombotic Events (TEs)	Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)	Thrombotic events will be reported as adverse events of special interest (AESI) and will include: acute ischemic stroke, acute myocardial infarction (AMI), and acute venous thromboembolism (VTE) events including (deep vein thrombosis (DVT), cerebral venous thrombosis (CVT), pulmonary embolism (PE).
Number of Participants With Acute kidney injury (AKI)	Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)	AKI will be reported as AESI and will include acute renal failure.
Number of Participants With Hemolytic Events (HEs)	Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)	HEs will be reported as AESI and will include nonautoimmune hemolytic anemia, acquired hemolytic anemia, ABO incompatibility reaction, or hemolytic transfusion reaction.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Anaphylaxis	Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)	Anaphylaxis will be reported as adverse event (AE) and will include anaphylactic reaction or anaphylactic shock.
Number of Participants With Transfusion-related Acute Lung Injury (TRALI)	Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)	Number of participants with TRALI will be reported.
Number of Participants With Transfusion-associated Circulatory Overload (TACO)	Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)	Number of participants with TACO will be reported.

Trial Locations

Locations (1)

RTI Health Solutions; 🇺🇸 Durham, North Carolina, United States