Post marketing surveillance program of PraxbindTM use in (PraxbindTM India PMS program)

Study identification

• EU PAS number:
  EUPAS21619
• Study ID:
  34131
• Official title and acronym:
  Post marketing surveillance program of PraxbindTM use in (PraxbindTM India PMS program)
• DARWIN EU® study:
  No
• Study countries:
  India
• Study description:
  The main objective of the PraxbindTM administration surveillance program is to evaluate the prescription patterns of use of PraxbindTM in a clinical practice setting, with special focus on ADRs and fatal AEs. Primary Outcome:-Any suspected ADRs and fatal AEs, with special focus on hypersensitivity and thrombotic event, occurred within 7 days after PraxbindTM administration.
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

AIIMS New Delhi, Sir HN Reliance Foundation Hospiat Mumbai, Dr L H Hiranandani Hospital Mumbai, St. John's Medical College and Hospital Bengaluru, Apollo Hospital Chennai, Medanta, The Medicity New Delhi, Batra Hospital and Medical Research Centre New Delhi, Sir Ganga Ram Hospital New Delhi, Holy Family hospital Mumbai, Nizams Institute of Medical Sciences  Hyderabad

Study timelines

Date when funding contract was signed

Planned:19/07/2017

Actual:19/07/2017

Study start date

Planned:20/12/2018

Data analysis start date

Planned:19/03/2020

Date of final study report

Planned:20/04/2020

Actual:06/10/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim India Pvt. Ltd.

Regulatory

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

Other study registration identification numbers and links

1321-0023
NCT03359889