Study identification

EU PAS number

EUPAS46101

Study ID

50068

Official title and acronym

TAK-771-4002: Evaluating the Safety of GAMMAGARD LIQUID for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

DARWIN EU® study

No

Study countries

United States

Study description

This study evaluates the safety of GAMMAGARD LIQUID (GGL) in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in real-world healthcare delivery databases in the United States: IBM MarketScan Research Databases, and Optum Clinformatics Data Mart. The primary objectives are to evaluate rates of adverse events of special interest (thrombosis, acute kidney injury, hemolysis) among patients with CIDP initiating GGL compared with rates among patients with CIDP initiating comparator intravenous immunoglobulin (IVIG) products. IVIG initiation and use will be evaluated with medical procedure and pharmacy claims data. CIDP status and other patient demographic and clinical characteristics will be evaluated with medical diagnosis, procedure, and pharmacy dispensing coding and enrollment information on or before IVIG initiation. The analysis will be conducted separately in each data source, and pooled estimates will be calculated if appropriate. Primary outcomes (thrombosis, AKI, hemolysis) and other secondary outcomes will be evaluated in medical diagnosis claims data using claims-based algorithms validated in IVIG users, when available.

Study status

Finalised
Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
Institution Not-for-profit ENCePP partner

Contact details

Study contact Takeda

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of final study report

Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Takeda
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable