The special drug use-results survey (All-Case Surveillance) of Ofev® Capsules in patients with Idiopathic Pulmonary Fibrosis (IPF) in Japan

Study identification

• EU PAS number:
  EUPAS10891
• Study ID:
  39448
• Official title and acronym:
  The special drug use-results survey (All-Case Surveillance) of Ofev® Capsules in patients with Idiopathic Pulmonary Fibrosis (IPF) in Japan
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  It is to evaluate the real-world safety and effectiveness of Ofev Capsules treatment in patients with IPF.
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Actual:13/07/2015

Study start date

Actual:31/08/2015

Data analysis start date

Actual:31/08/2015

Date of final study report

Planned:31/05/2024

Actual:25/03/2024

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