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

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05363358
• Other study ID #: TAK-771-4002
• Secondary ID: EUPAS46101
• Status: Completed
• Start date: May 27, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: April 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6086
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
• Polyradiculoneuropathy
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Locations

Country	Name	City	State
United States	RTI Health Solutions	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Takeda	Baxalta Innovations GmbH, now part of Shire, RTI Health Solutions

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

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