A Multi-Country Prospective Multi-Drug Resistant Tuberculosis Patient Registry to Monitor Bedaquiline Safety, Utilization, and Emergence of Resistance

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40892
• EU PAS number:
  EUPAS16023
• Study ID:
  40892
• Official title and acronym:
  A Multi-Country Prospective Multi-Drug Resistant Tuberculosis Patient Registry to Monitor Bedaquiline Safety, Utilization, and Emergence of Resistance
• DARWIN EU® study:
  No
• Study countries:
  Hong Kong

  Korea, Republic of

  Philippines

  South Africa

  Thailand
• Study description:
  This study is a prospective, multi-country MDR-TB registry to further assess the benefits and risks of BDQ by evaluating BDQ safety, effectiveness, and emergence of resistance, BDQ drug utilization, and adherence to WHO guidance on the use of BDQ in MDR-TB treatment.
• Study status:
  Finalised

Research institution and networks

Institutions

Johnson & Johnson

Study timelines

Date when funding contract was signed

Actual: 14/09/2015

Study start date

Actual: 03/05/2016

Date of final study report

Planned: 30/12/2020

Actual: 26/10/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen Research & Developmentt

Study protocol

Initial protocol

TMC207TBC4002_Multi Country MDRTB Registry Protocol v2.0

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)