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

NCT05363358 | Completed

• 2 other identifiers: TAK-771-4002EUPAS46101
• Study Type: observational
• Target: 6,086
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Thrombotic Events (TEs)

  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).

  Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)

• Number of Participants With Acute kidney injury (AKI)

  AKI will be reported as AESI and will include acute renal failure.

  Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)

• Number of Participants With Hemolytic Events (HEs)

  HEs will be reported as AESI and will include nonautoimmune hemolytic anemia, acquired hemolytic anemia, ABO incompatibility reaction, or hemolytic transfusion reaction.

  Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)

Secondary Outcomes (3)

• Number of Participants With Anaphylaxis

  Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)

• 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 Transfusion-associated Circulatory Overload (TACO)

  Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)

Study Arms (2)

Ig-naive (New-to-class) Cohort

Participants who initiate GGL or one of the comparator IVIG products who have no record of previous use of any Ig product (Ig naive) for at least 6 months before study initiation will be include in this cohort.

Ig-experienced (New-to-drug) Cohort

Participants who initiate either GGL or a comparator IVIG product with no record of previous use of that specific IVIG product but with previous use of any other Ig product (Ig experienced) in all available study data will be included in this cohort.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with CIDP on treatment with GGL and other IVIG products will be observed in this retrospective study.

You may qualify if:

• 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.
• Be free of any previous recorded use of any Ig product at any point before IVIG initiation.
• Have any previous recorded use of an Ig product at any point before the index date.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead
• Baxalta Innovations GmbH, now part of Shire: collaborator
• RTI Health Solutions: collaborator

Study Sites (1)

RTI Health Solutions

Durham, North Carolina, 12194, United States

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 5, 2022
• Study Start: May 27, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)