Privigen® use and haemolytic anaemia in adults and children and the Privigen® safety profile in children with CIDP - an observational hospital-based cohort study in the US (Privigen PASS)

12/03/2014
14/03/2024
EU PAS number:
EUPAS6040
Study
Ongoing
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Study identification

EU PAS number

EUPAS6040

Study ID

29795

Official title and acronym

Privigen® use and haemolytic anaemia in adults and children and the Privigen® safety profile in children with CIDP - an observational hospital-based cohort study in the US (Privigen PASS)

DARWIN EU® study

No

Study countries

United States

Study description

This study is a 2-part retrospective and prospective hospital-based observational cohort study with objectives to:1. Estimate the incidence of haemolytic anemia (HA), in adults and children, before and after implementation of risk minimization measures in the process of screening of plasma donors and in the manufacturing process of Privigen®.2. Evaluate the safety profile of Privigen® in children (0-18 years) with chronic inflammatory demyelinating polyneuropathy (CIDP).Part 1 of the study will compare results from three separate calendar-time periods (Jan 2008 to Dec 2012, Oct 2013 to Dec 2015 and Oct 2016 to Apr 2019) to assess the effect of the risk minimization measures. Part 2 will analyse data accumulated over the whole study period to assess the adverse event (AE) profile in children with CIDP.The data source is the Premier Perspective™ database in the United States.Study Population: Adult and paediatric patients with at least one dispensing for Privigen® in US hospitals contributing to the Premier Perspective™ database. As of the writing of the first and second interim reports for this study, the Premier database contained data on 8,993 and 7,710 adult and paediatric patients administered Privigen between 1 January 2008 and 31 December 2012 (Period 1: baseline) and between 1 October 2013 and 31 December 2015 (Period 2) respectively.Seventeen patients aged <18 were treated with Privigen® for CIDP between 1 January 2008 and 31 December 2015 . Variables: The exposure of interest is Privigen®. The outcome in both adults and children in Part 1 of the study is the incidence of HA. The outcome variables to be assessed in children with CIDP in Part 2 of the study include diagnosis codes for aseptic meningitis, acute renal failure, thromboembolic events and anaphylactic reactions

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Carlos Martinez

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

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Data analysis start date

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Date of interim report, if expected

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Date of final study report

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Sources of funding
Pharmaceutical company and other private sector 

More details on funding

CSL Behring
Regulatory

Was the study required by a regulatory body?

No

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

EU RMP category 3 (required)