TAK-660-403: Evaluation of Long-term Safety of ADYNOVI/ADYNOVATE (Antihaemophilic Factor [Recombinant] PEGylated, Rurioctocog Alfa Pegol) in Patients With Haemophilia A - An ADYNOVI/ADYNOVATE Post-Authorisation Safety Study (PASS) (TAK-660-403: ADYNOVI/ADYNOVATE PASS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50722
• EU PAS number:
  EUPAS35698
• Study ID:
  50722
• Official title and acronym:
  TAK-660-403: Evaluation of Long-term Safety of ADYNOVI/ADYNOVATE (Antihaemophilic Factor [Recombinant] PEGylated, Rurioctocog Alfa Pegol) in Patients With Haemophilia A - An ADYNOVI/ADYNOVATE Post-Authorisation Safety Study (PASS) (TAK-660-403: ADYNOVI/ADYNOVATE PASS)
• DARWIN EU® study:
  No
• Study countries:
  Bulgaria

  Croatia

  Czechia

  Germany

  Hungary

  Italy

  Korea, Republic of

  Netherlands

  Spain

  Sweden

  Taiwan
• Study description:
  The main aim of this study is to check for long-term side effects from ADYNOVI/ADYNOVATE prophylaxis in participants with haemophilia A when used under standard clinical practice in the real-world clinical setting.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Takeda

Baxalta Innovations GmbH

Study timelines

Date when funding contract was signed

Planned: 24/04/2019

Actual: 10/03/2020

Study start date

Planned: 20/07/2020

Actual: 09/07/2020

Date of final study report

Planned: 22/07/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Baxalta Innovations GmbH, now part of Takeda

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)
• Regulatory procedure number:
  EMEA/H/C/PSA/S/0045.1

Other study registration identification numbers and links

NCT04158934,https://clinicaltrials.gov/ct2/show/NCT04158934?term=NCT04158934&draw=2&rank=1