REFINE: Regorafenib observational study in hepatocellular carcinoma

Study identification

• EU PAS number:
  EUPAS20981
• Study ID:
  50372
• Official title and acronym:
  REFINE: Regorafenib observational study in hepatocellular carcinoma
• DARWIN EU® study:
  No
• Study countries:
  Albania

  Algeria

  Argentina

  Austria

  Belgium

  Brazil

  Canada

  China

  Denmark

  Egypt

  France

  Greece

  India

  Italy

  Japan

  Korea, Republic of

  Lebanon

  Luxembourg

  Mexico

  Netherlands

  Oman

  Russian Federation

  Saudi Arabia

  Spain

  Sweden

  Taiwan

  Thailand

  Türkiye

  United Arab Emirates

  United States
• Study status:
  Finalised

Research institutions and networks

Institutions

Bayer AG

Multiple centres: 150 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 17/03/2017

Actual: 23/02/2017

Study start date

Planned: 30/09/2017

Actual: 13/09/2017

Date of interim report, if expected

Planned: 22/04/2020

Date of final study report

Planned: 30/11/2022

Actual: 12/10/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

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)