ConTTRibute: A Global Observational Multicenter Long-Term Study of Patients with Transthyretin (TTR)-Mediated Amyloidosis (ATTR amyloidosis)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000381
• EU PAS number:
  EUPAS1000000381
• Study ID:
  1000000381
• Official title and acronym:
  ConTTRibute: A Global Observational Multicenter Long-Term Study of Patients with Transthyretin (TTR)-Mediated Amyloidosis (ATTR amyloidosis)
• DARWIN EU® study:
  No
• Study countries:
  Brazil

  Bulgaria

  Denmark

  France

  Germany

  Israel

  Italy

  Netherlands

  Portugal

  Spain

  Taiwan

  United States
• Study description:
  The purpose of this study is to:; - Describe epidemiological and clinical characteristics, natural history and real-world clinical management of ATTR amyloidosis patients; - Characterize the safety and effectiveness of patisiran and vutrisiran as part of routine clinical practice in the real-world clinical setting; - Describe disease emergence/progression in pre-symptomatic carriers of a known disease-causing transthyretin (TTR) variant
• Study status:
  Ongoing

Research institutions and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

Study timelines

Date when funding contract was signed

Actual: 02/09/2020

Study start date

Actual: 23/11/2020

Date of final study report

Planned: 01/09/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Alnylam

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

ALN-TTRSC02-013, NCT04561518

Link to ClinicalTrials.gov