Study identification

PURI

https://redirect.ema.europa.eu/resource/24963

EU PAS number

EUPAS6987

Study ID

24963

Official title and acronym

Viread Observational, Cross -Sectional Drug Utilisation Study in Children and Adolescents with Chronic Hepatitis B (Viread HBV DUS)

DARWIN EU® study

No

Study countries

Austria
Belgium
Bulgaria
Denmark
Estonia
France
Germany
Hungary
Italy
Netherlands
Poland
Portugal
Romania
Spain
Sweden
United Kingdom

Study description

GS-EU-174-0224: This observational cross-sectional drug utilisation study uses a study-specific questionnaire that will capture the respective aggregated data on Viread use, pre-treatment and on-treatment assessments and management of renal and bone toxicities. The participating physicians will complete questionnaires using their patient medical records retrospectively. Data will not be collected on the individual patient level, but will be aggregated at the site level. Physicians will be sent 3 separate questionnaires over a 3-year period on information regarding paediatric patients with CHB under care in their practices.

Study status

Finalised
Research institutions and networks

Institutions

Gilead Sciences
First published:
12/02/2024
InstitutionPharmaceutical company
Multiple centres: 35 centres are involved in the study

Contact details

Gilead Study Director

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences Inc.
Study protocol
Initial protocol

amd-1-prot GS-EU-174-0224 FINAL COMPLETE

English (259.01 KB - PDF)View document
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)