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

Study identification

• 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:
  Finalised

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

Data analysis start date

Planned:03/03/2025

Date of final study report

Planned:31/12/2025

Actual:26/09/2025

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