Study identification

PURI

https://redirect.ema.europa.eu/resource/107783

EU PAS number

EUPAS107650

Study ID

107783

Official title and acronym

DARWIN EU® Characterization of patients with chronic hepatitis B and C

DARWIN EU® study

Yes

Study countries

Estonia
France
Germany
Netherlands
Spain
United Kingdom

Study description

Sustainable Development Goals for 2030 set by UN Member States include Target 3.3 states, calling for an end to epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases and combat hepatitis, water-borne diseases and other communicable diseases. The 2016 WHO Global Health Sector Strategy (GHSS) aims to eliminate viral hepatitis by 2030, and WHO EU has developed a hepatitis action plan to steer the implementation of the GHSS in Europe. The European Centre for Disease Prevention and Control (ECDC) has developed a monitoring system for Hepatitis B Viral Infection (HBV) and Hepatitis C Viral Infection (HCV) aligned with indicators and targets of the GHSS and the WHO European Region Action Plan. Comprehensive data on the prevalence of chronic HBV or HCV infections and utilisation of antiviral treatments for chronic HBV or HCV infections are important to monitor progress towards the elimination targets related to treatment, to adjust prevalence estimates over time, and to support effective planning of prevention and control activities by countries. This DARWIN EU imitative aims to provide robust and timely data at national or subnational level. The aims are to report the number and percentage of patients diagnosed with chronic HBV or HCV infection who initiate or undergo treatment with interferon or any specified antivirals, to characterize patients with chronic HBV or HCV infection at the initiation of treatment with interferon or specified antivirals and to estimate the proportion of all patients with chronic HBV or HCV infection. All the analyses will be stratified by age, sex, calendar year, and database during the study period 2012 to 2022.

Study status

Finalised
Research institution and networks

Networks

Contact details

Katia Verhamme

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

DARWIN EU_D2.2.3_Protocol_P2-C1-010_HBV_HCV_Pts_Characterisation_v2.1.pdf

English (951.11 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable