Post-marketing Surveillance of Ofev Capsules in Chronic (PMS for PF-ILD)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40512
• EU PAS number:
  EUPAS36605
• Study ID:
  40512
• Official title and acronym:
  Post-marketing Surveillance of Ofev Capsules in Chronic (PMS for PF-ILD)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  The primary objective is to evaluate the incidence of adverse drug reactions (focus on hepatic function disorders) of Ofev Capsules under the real world setting in patients with PF-ILD.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned: 10/09/2020

Actual: 28/09/2020

Study start date

Planned: 01/10/2020

Actual: 02/10/2020

Date of final study report

Planned: 31/12/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Nippon Boehringer Ingelheim Co., Ltd.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only