Alecensa Survey to Prescribers: Effectiveness Measure to Investigate the Correct Implementation of Alecensa Label Guidance by Prescribers

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37931
• EU PAS number:
  EUPAS29244
• Study ID:
  37931
• Official title and acronym:
  Alecensa Survey to Prescribers: Effectiveness Measure to Investigate the Correct Implementation of Alecensa Label Guidance by Prescribers
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Germany

  Hungary

  Italy

  Spain

  Sweden

  United Kingdom
• Study description:
  The aim of this study is to evaluate the effectiveness of Alecensa's risk minimization measures (RMM) for the important identified risks (interstitial lung disease (ILD)/pneumonitis, hepatoxicity, bradycardia, photosensitivity, severe myalgia, and CPK elevations) as outlined in the risk management plan (RMP) and label, by assessing their correct implementation by Health Care Professionals (HCPs).
• Study status:
  Finalised

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 17/11/2018

Study start date

Planned: 01/06/2019

Actual: 22/05/2019

Date of final study report

Planned: 01/12/2020

Actual: 23/10/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

F. Hoffmann-La Roche Ltd

Study protocol

Initial protocol

ALECENSA_Final Redacted_02 April 2019

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)