Post-Authorisation Safety Study of Esbriet® (Pirfenidone): A Prospective Observational Registry to Evaluate Long-Term Safety in Real-World Setting (PASSPORT)

Study identification

• EU PAS number:
  EUPAS2165
• Study ID:
  23388
• Official title and acronym:
  Post-Authorisation Safety Study of Esbriet® (Pirfenidone): A Prospective Observational Registry to Evaluate Long-Term Safety in Real-World Setting (PASSPORT)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Idiopathic pulmonary fibrosis (IPF) is a progressive illness with an extremely poor prognosis, median survival after diagnosis is 2-5 years. Esbriet® is an orally bioavailable small synthetic non-peptide molecule that attenuates fibroblast proliferation, production of fibrosis-associated proteins and cytokines, and the increased biosynthesis and accumulation of extracellular matrix in response to cytokine growth factors such as transforming growth factor-beta and platelet-derived growth factor. Esbriet® is authorised for the treatment of mild to moderate IPF. Although data from the development programme including Phase 3 trials demonstrate that Esbriet® has an acceptable risk benefit profile in the treatment of mild to moderate IPF, there is a need, in real-world clinical practice, to establish the long-term safety profile of Esbriet® treatment. The objective of this study is to evaluate the long-term safety profile of Esbriet® in patients with IPF and to monitor for any unknown or potential risks of treatment with Esbriet®. This product registry is a multicentre, long-term, prospective, observational study to evaluate the long-term safety of Esbriet® in patients with IPF. Patients will receive Esbriet® at the discretion of their physicians and will be followed through the registry for 2 years after they begin treatment with Esbriet®. This registry complies with the requirement of a post-authorisation safety study (PASS) and is a post-authorisation commitment, which has been approved by the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA). The registry is observational, therefore, all treatment decisions are at the discretion of the patient’s health care provider and are not mandated by study design or protocol. Cooperation of health care professionals is based on goodwill and no contractual sanctions will be applied by the MAH.
• Study status:
  Finalised

Research institutions and networks

Institutions

N/A

Multiple centres: 106 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:01/12/2011

Actual:01/12/2011

Study start date

Planned:15/02/2012

Actual:16/02/2012

Date of final study report

Planned:30/09/2017

Actual:28/04/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

F Hoffmann La Roche, Ltd.

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)

Other study registration identification numbers and links

WB29908