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Completed

NCT Number: NCT05363358

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

RTI Health Solutions

Durham, North Carolina, 12194, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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
  • 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.

Treatment and study plan

Primary outcomes

  1. Number of Participants With Thrombotic Events (TEs)

    Time frame: 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).

  2. Number of Participants With Acute kidney injury (AKI)

    Time frame: 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.

  3. Number of Participants With Hemolytic Events (HEs)

    Time frame: 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 outcomes

  1. Number of Participants With Anaphylaxis

    Time frame: 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.

  2. Number of Participants With Transfusion-related Acute Lung Injury (TRALI)

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

    Number of participants with TRALI will be reported.

  3. Number of Participants With Transfusion-associated Circulatory Overload (TACO)

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

    Number of participants with TACO will be reported.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Collaborators

  • Baxalta Innovations GmbH, now part of Shire
  • RTI Health Solutions

Registry information

Official study title

Evaluating the Safety of GAMMAGARD LIQUID for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 5, 2022
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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