A THAOS Sub-Study Evaluating the Effects of Tafamidis on Disease Progression in Patients with non-V30M Mutations and Symptomatic Neuropathy

Study identification

• EU PAS number:
  EUPAS4027
• Study ID:
  48109
• Official title and acronym:
  A THAOS Sub-Study Evaluating the Effects of Tafamidis on Disease Progression in Patients with non-V30M Mutations and Symptomatic Neuropathy
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Belgium

  Brazil

  Bulgaria

  Cyprus

  Denmark

  France

  Germany

  Israel

  Italy

  Japan

  Mexico

  Portugal

  Spain

  Sweden

  Taiwan

  United States
• Study status:
  Finalised

Research institutions and networks

Institutions

ICON Commercialisation & Outcomes

Germany

Ireland

Multiple centres: 52 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:30/06/2013

Actual:24/05/2013

Study start date

Planned:30/06/2013

Actual:30/07/2013

Date of final study report

Planned:31/05/2022

Actual:11/04/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 2 (specific obligation of marketing authorisation)

Other study registration identification numbers and links

B3461029