DAA-PASS: A Post-Authorisation Safety Study of Early Recurrence of Hepatocellular Carcinoma in HCV-Infected Patients after Direct-Acting Antiviral Therapy

Study identification

• EU PAS number:
  EUPAS22896
• Study ID:
  47600
• Official title and acronym:
  DAA-PASS: A Post-Authorisation Safety Study of Early Recurrence of Hepatocellular Carcinoma in HCV-Infected Patients after Direct-Acting Antiviral Therapy
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Spain

  United States
• Study description:
  This prospective, observational study will estimate the risk of early HCC recurrence associated with DAA therapy exposure relative to no DAA therapy exposure during routine clinical care of HCV-infected patients with previous successfully treated HCC using a prospective cohort from TARGET HCC.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 60 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:12/02/2018

Actual:12/02/2018

Study start date

Planned:05/03/2018

Actual:29/03/2018

Date of final study report

Planned:31/12/2021

Actual:15/12/2021

Sources of funding

Other

More details on funding

TARGET PharmaSolutions, Inc.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)