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NCT05363358 · ClinicalTrials.gov registry record
A Safety Study of GAMMAGARD LIQUID (GGL) in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
A clinical trial, sponsored by Takeda.
- Completed
- Registry status
- 6,086
- Enrollment target
NCT05363358: Completed study, sponsored by Takeda.
NCT05363358 is a clinical trial that has completed, run by Takeda. The registered enrollment target is 6,086 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05363358 has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- 6,086 participants
- Enrollment target
Study 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.
Primary Outcome
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).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,086 participants |
| Start Date | 2022-05-27 |
| Est. Completion | 2022-12-01 |
What the finished NCT05363358 record still lists
NCT05363358 is an observational study that tracks outcomes without assigning an intervention. Its 6,086 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT05363358 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05363358 about?
NCT05363358 is a clinical study titled "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 immu...
What is the current status of trial NCT05363358?
This trial is currently completed. The enrollment target is 6,086 participants. The study started on 2022-05-27. Estimated completion is 2022-12-01.
Who is sponsoring clinical trial NCT05363358?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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