A Multicentre, EU-wide, Non-Interventional Post-Authorisation Study to Assess the Safety and Usage of Delamanid In Routine Medical Practice in Multidrug-Resistant Tuberculosis Patients.

Study identification

• EU PAS number:
  EUPAS10618
• Study ID:
  49710
• Official title and acronym:
  A Multicentre, EU-wide, Non-Interventional Post-Authorisation Study to Assess the Safety and Usage of Delamanid In Routine Medical Practice in Multidrug-Resistant Tuberculosis Patients.
• DARWIN EU® study:
  No
• Study countries:
  Estonia

  France

  Germany

  Latvia

  Lithuania

  United Kingdom
• Study description:
  The objectives of the Study are: 1. to monitor the usage of Deltyba in a real-life setting when prescribed as part of an ACR "Appropriate combination regimen" designed by the treating physician, 2. to evaluate treatment outcomes (including clinical effectiveness) as defined by the WHO and / or national guidelines for patients at the end of a full trial treatment period for MDR-TB "Multidrug-resistant tuberculosis" up to 30 months, or earlier if patients are cured, 3. to monitor the safety of Deltyba in a real-life setting when prescribed as part of an ACR designed by the treating physician.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual:02/01/2014

Study start date

Planned:31/12/2015

Actual:12/08/2016

Data analysis start date

Planned:30/06/2022

Actual:30/09/2021

Date of final study report

Planned:30/09/2022

Actual:16/09/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Otsuka Novel Products GmbH

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)