Monitoring of pregnancy outcomes in women treated with inclisiran: a non-interventional study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50706
• EU PAS number:
  EUPAS42905
• Study ID:
  50706
• Official title and acronym:
  Monitoring of pregnancy outcomes in women treated with inclisiran: a non-interventional study
• DARWIN EU® study:
  No
• Study countries:
  Switzerland
• Study description:
  This post-authorisation safety study is a worldwide, single-arm descriptive non-interventional study that collects prospective and retrospective data in women exposed to inclisiran during pregnancy. It uses an enhanced pharmacovigilance data collection and processing system via a set of targeted checklists, structured follow-up, rigorous process of data entry and data quality control, and programmed aggregate analysis. The overall objective of the study is to collect data on pregnancy outcomes in patients treated with inclisiran during or prior to pregnancy. Although pharmacovigilance data may be collected from any country in the world where the product is approved, the anonymized patient level data will be analyzed at a global level in Switzerland.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned: 09/12/2020

Actual: 09/12/2020

Study start date

Planned: 31/12/2021

Actual: 31/12/2021

Data analysis start date

Planned: 31/01/2031

Date of final study report

Planned: 31/07/2031

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma AG

Study protocol

Initial protocol

CKJX839A12011-v00--protocol_Redacted

Updated protocol

CKJX839A12011_Protocol V2_Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

CKJX839A12011