An active surveillance to monitor the real world safety in Indian patients prescribed nintedanib for the treatment of Idiopathic Pulmonary Fibrosis

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40189
• EU PAS number:
  EUPAS17055
• Study ID:
  40189
• Official title and acronym:
  An active surveillance to monitor the real world safety in Indian patients prescribed nintedanib for the treatment of Idiopathic Pulmonary Fibrosis
• DARWIN EU® study:
  No
• Study countries:
  India
• Study description:
  This is an active surveillance study to monitor the real workd safety of nintedanib in Indian patients with Idiopathic Pulmonary Fibrosis. The safety of nintedanib has been assessed in Clinical Trials. Since only 20 patients in India were enrolled in the Inpulsis trials, the safety data on Indian patients is limited. In this active surveillance, the safety of nintedanib in IPF patients will be examined in Indian real world setting.
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

NAABI Kolkata, Bhatia Hospital Mumbai, Narayana Hrudayalaya Bangalore, Sterling Hospital Ahmedabad, Hinduja Hospital Mumbai, Ruby Hall Pune, Asthma Bhavan Jaipur, King George Medical University Lucknow, Midland Healthcare and Research Center Lucknow, The Calcutta Medical Research Institute Kolkata

Study timelines

Date when funding contract was signed

Planned: 21/01/2017

Actual: 21/01/2017

Study start date

Planned: 24/02/2017

Actual: 01/05/2017

Data analysis start date

Planned: 28/02/2017

Actual: 01/05/2017

Date of final study report

Planned: 31/10/2023

Actual: 23/10/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Study protocol

Initial protocol

clinical-trial-protocol-amendment-01_2

Updated protocol

1199-0280-Protocol-V5

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable