Trials / Completed
CompletedNCT05363358
A Safety Study of GAMMAGARD LIQUID (GGL) in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Evaluating the Safety of GAMMAGARD LIQUID for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 6,086 (actual)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2022-05-27
- Primary completion
- 2022-12-01
- Completion
- 2022-12-01
- First posted
- 2022-05-05
- Last updated
- 2023-05-01
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05363358. Inclusion in this directory is not an endorsement.