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

NCT05363358 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6086

Last updated 2023-05-01

No results posted yet for this 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.

Conditions

  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Sponsors & Collaborators

  • Baxalta Innovations GmbH, now part of Shire

    collaborator INDUSTRY

  • RTI Health Solutions

    collaborator OTHER

  • Takeda

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-27
Primary Completion
2022-12-01
Completion
2022-12-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05363358 on ClinicalTrials.gov