Prevalence of immunology testing in patients treated with alglucosidase alfa with significant hypersensitivity/anaphylactic reactions (ALGMYC07390)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37523
• EU PAS number:
  EUPAS10526
• Study ID:
  37523
• Official title and acronym:
  Prevalence of immunology testing in patients treated with alglucosidase alfa with significant hypersensitivity/anaphylactic reactions (ALGMYC07390)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany
• Study status:
  Finalised

Research institutions and networks

Institutions

Sanofi

Study timelines

Date when funding contract was signed

Planned: 23/03/2015

Actual: 23/03/2015

Study start date

Planned: 31/12/2015

Actual: 01/07/2016

Data analysis start date

Planned: 30/09/2016

Actual: 30/09/2016

Date of interim report, if expected

Planned: 31/12/2016

Actual: 23/12/2016

Date of final study report

Planned: 31/08/2019

Actual: 12/12/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Genzyme Europe B.V., The Netherlands

Study protocol

Initial protocol

rdct-ALGMYC07390_study protocol_V3_final 14dec2015_approved-PDFA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

ALGMYC07390