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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50068
• 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

Study timelines

Date when funding contract was signed

Actual: 02/02/2022

Study start date

Actual: 28/05/2022

Data analysis start date

Actual: 28/05/2022

Date of final study report

Actual: 21/03/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Study protocol

Initial protocol

TAK-771-4002-protocol-original_redact

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable