A study to evaluate the risk of de novo hepatocellular carcinoma in patients with compensated cirrhosis treated with direct-acting antivirals for chronic hepatitis C (De Novo DAA PASS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44706
• EU PAS number:
  EUPAS30818
• Study ID:
  44706
• Official title and acronym:
  A study to evaluate the risk of de novo hepatocellular carcinoma in patients with compensated cirrhosis treated with direct-acting antivirals for chronic hepatitis C (De Novo DAA PASS)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Evaluate the potential risk of de novo hepatocellular carcinoma following direct-acting antiviral treatment in hepatitis C virus infected patients with compensated cirrhosis without a history of hepatocellular carcinoma.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual: 07/04/2020

Study start date

Actual: 06/04/2020

Date of final study report

Planned: 14/12/2021

Actual: 19/11/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie; Gilead Sciences; Merck Sharp & Dohme

Study protocol

Initial protocol

denovo-daa-pass-protocol_v3_abstract_01Aug2019

Updated protocol

denovo-daa-pass-protocol_v3_redacted

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)

Other study registration identification numbers and links

B20-146