Non-Interventional Post-Authorization Safety Study on the Long-Term Safety of HyQvia in Subjects Treated with HyQvia (161302)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43051
• EU PAS number:
  EUPAS5812
• Study ID:
  43051
• Official title and acronym:
  Non-Interventional Post-Authorization Safety Study on the Long-Term Safety of HyQvia in Subjects Treated with HyQvia (161302)
• DARWIN EU® study:
  No
• Study countries:
  Czechia

  Denmark

  Germany

  Ireland

  Italy

  Netherlands
• Study description:
  This study is a non-interventional, prospective, uncontrolled, open-label, multi-center, post-authorization safety study to evaluate the long-term safety of HyQvia under clinical routine conditions. The HyQvia dosage regimen and treatment schedule will be chosen by the attending physician in accordance with routine clinical practice. There will be no required predefined visits, medical tests, laboratory tests and procedures beyond the treatment center’s standard clinical practice during the course of the study, except for the assessment of antibodies to recombinant human hyaluronidase (rHuPH20) which was a request of the Committee for Medicinal Products for Human Use (CHMP).
• Study status:
  Finalised

Research institutions and networks

Institutions

Shire

Multiple centres: 25 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 17/12/2013

Actual: 17/12/2013

Study start date

Planned: 30/07/2014

Actual: 17/07/2014

Data analysis start date

Actual: 14/02/2020

Date of final study report

Actual: 16/07/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Baxalta Innovations GmbH, now part of Shire

Study protocol

Initial protocol

161302-protocol-original-redact

Updated protocol

161302-protocol-amendment 3-redact

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)