A Registry of Patients Treated with Fintepla (TAPESTRY Registry)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105359
• EU PAS number:
  EUPAS105358
• Study ID:
  105359
• Official title and acronym:
  A Registry of Patients Treated with Fintepla (TAPESTRY Registry)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Denmark

  France

  Germany

  Italy

  Spain

  United Kingdom
• Study description:
  This observational, multi-country, cohort study (a registry) will assess the long-term cardiac safety of fenfluramine as prescribed in routine clinical practice for fenfluramine approved indications, with focus on incidence of valvular heart disease (VHD) and incidence of pulmonary arterial hypertension (PAH).
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Actual: 01/09/2022

Study start date

Actual: 09/06/2023

Date of final study report

Planned: 02/01/2034

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Zogenix International Ltd. (now part of UCB)

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/003933

Other study registration identification numbers and links

ZX008-2101 (EP0218)