Post Authorization Safety Study of Nintedanib in the treatment of patients with Idiopathic Pulmonary fibrosis in Argentina

Study identification

• EU PAS number:
  EUPAS18150
• Study ID:
  18151
• Official title and acronym:
  Post Authorization Safety Study of Nintedanib in the treatment of patients with Idiopathic Pulmonary fibrosis in Argentina
• DARWIN EU® study:
  No
• Study countries:
  Argentina
• Study description:
  According to the Orphan Drug regulation currently in force in Argentina (Provision 4622/2012, Annex I, Paragraph 2), BI must implement a registry of all patients with idiopathic pulmonary fibrosis (IPF) receiving nintedanib.The following registry objectives have been defined for all IPF patients receiving treatment with nintedanib in Argentina:1. To determine the baseline characteristics of the IPF population receiving treatment with nintedanib (with population stratified based on whether it had received prior treatment with pirfenidone, other therapies for IPF or no treatment).2. To collect data on adverse events in patients receiving nintedanib.The following registry objectives have been defined for IPF patients from two tertiary care centers (Hospital María Ferrer, located in Buenos Aires, and Hospital Cetrángolo, located in Vicente López):1. To determine the baseline characteristics of all IPF patients at two tertiary care centers.2. To collect adverse event data from patients receiving nintedanib (with population stratified based on whether it had received prior treatment with pirfenidone, other therapies for IPF or no treatment).3. To obtain an overall patient-reported assessment, as measured by the Patient Global Rating (PGR) scale, from patients newly diagnosed with IPF receiving treatment with nintedanib.4. To evaluate the decline in lung function, as measured by forced vital capacity (FVC), in patients newly diagnosed with IPF receiving treatment with nintedanib.
• Study status:
  Planned

Research institutions and networks

Institutions

Hospital Cetrángolo

Study timelines

Date when funding contract was signed

Planned: 27/03/2017

Study start date

Planned: 03/04/2017

Date of final study report

Planned: 07/03/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable