A Retrospective, Non-interventional, Multi-centre Study of TEGSEDI-treated Patients to Evaluate Real-world Adherence to, and Effectiveness of the Recommendations for Platelet Monitoring, Dose Adjustment, and Steroid Initiation to Manage Risk of Thrombocytopenia (TEG4002)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37732
• EU PAS number:
  EUPAS37731
• Study ID:
  37732
• Official title and acronym:
  A Retrospective, Non-interventional, Multi-centre Study of TEGSEDI-treated Patients to Evaluate Real-world Adherence to, and Effectiveness of the Recommendations for Platelet Monitoring, Dose Adjustment, and Steroid Initiation to Manage Risk of Thrombocytopenia (TEG4002)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Bulgaria

  Cyprus

  France

  Germany

  Greece

  Italy

  Portugal

  Spain

  Sweden

  United Kingdom
• Study description:
  This is a retrospective chart review study of patients who have commenced commercial TEGSEDI, at any time and for any duration, between the date of relevant marketing authorization of TEGSEDI and the date of data extraction. ; Patients will be enrolled in the study in 2025 and data will then be extracted from the medical records for the period from the start of commercial TEGSEDI treatment until 1) eight weeks after discontinuation of treatment with TEGSEDI, or 2) death. ; For those patients who are still on TEGSEDI at the time of enrollment, retrospective data collection will be censored from the time of informed consent. It is anticipated that at least 100 patients will be recruited. ; The goal of this study is to assess the real-world adherence to, and effectiveness of the proposed schedule for platelet monitoring, TEGSEDI dose adjustment, and initiation of steroids for platelet recovery in accordance with the schedule outlined in the Summary of Product Characteristics (SmPC).
• Study status:
  Ongoing

Research institutions and networks

Institutions

Akcea Therapeutics, Inc.

Study timelines

Date when funding contract was signed

Planned: 16/12/2019

Actual: 16/12/2019

Study start date

Planned: 01/01/2025

Actual: 26/03/2025

Date of final study report

Planned: 31/12/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Akcea Therapeutics, Inc.

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

TEG4002