Study identification

EU PAS number

EUPAS12456

Study ID

23871

Official title and acronym

A 2-Year Observational Study to Describe the Characteristics and Progression of Patients Suffering from Idiopathic Pulmonary Fibrosis Treated with Esbriet® in the Conditions of Use

DARWIN EU® study

No

Study countries

France

Study description

At request of the EMA, InterMune (acquired by Roche) initiated a European post-marketing safety study, PIPF-025 or PASSPORT, to evaluate the safety profile of long-term use of Esbriet in patients with IPF and to monitor the potential or unknown risks over two years of treatment with Esbriet.Given the necessity for improved understanding of the clinical outcomes in real life for patients with IPF treated with Esbriet, Roche now plans to implement the FAS (French Ancillary Study), an observational and ancillary study to the PASSPORT study at the request of the French authorities (Haute Autorité de Santé and Direction Générale de la Santé).Efficacy data will be collected in FAS at French sites only to complement the safety data obtained in the PASSPORT study. The PASSPORT study and the FAS will be conducted in parallel involving the same French sites, patients and Principal Investigators.

Study status

Finalised
Research institutions and networks

Institutions

Gilead Sciences Europe Ltd.
Multiple centres: 22 centres are involved in the study

Contact details

Astrid Scalori

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Roche
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable