Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)NCT05363358
A Safety Study of GAMMAGARD LIQUID (GGL) in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
An observational study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), run by Takeda at 1 site in United States.
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
- How many people
- 6,086 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2022to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with CIDP on treatment with GGL and other IVIG products will be observed in this retrospective study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Safety of GAMMAGARD LIQUID for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
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.
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)
Secondary outcomes (3)
Number of Participants With Anaphylaxis
Anaphylaxis will be reported as adverse event (AE) and will include anaphylactic reaction or anaphylactic shock.
Measured: 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)
Number of participants with TRALI will be reported.
Measured: Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)
Number of Participants With Transfusion-associated Circulatory Overload (TACO)
Number of participants with TACO will be reported.
Measured: Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start27 May 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,086 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxalta Innovations GmbH, now part of Shire, RTI Health Solutions
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363358
- Sponsor's protocol ID
- TAK-771-4002
- Other IDs
- EUPAS46101
- Status last verified
- Apr 2023
- First submitted
- 2 May 2022
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data from this particular study will not be shared as the data are subject to contractual (or consent) provisions that prohibit transfer to third parties.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety of GAMMAGARD LIQUID for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- ClinicalTrials.gov ID
- NCT05363358
- Acronym / sponsor ID
- TAK-771-4002
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,086 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Collaborators
- Baxalta Innovations GmbH, now part of Shire, RTI Health Solutions
- Study start
- 27 May 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with CIDP on treatment with GGL and other IVIG products will be observed in this retrospective study.
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
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.
3 secondary outcomes
Number of Participants With Anaphylaxis
Time frame: 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)
Time frame: Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: No. De-identified individual participant data from this particular study will not be shared as the data are subject to contractual (or consent) provisions that prohibit transfer to third parties.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), run by Takeda at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Thrombotic Events (TEs) (time frame: Throughout observational period, from 01 January 2008 to 31 December 2019 (Up to 12 years)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.