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

Study identification

• 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

Multiple centres: 35 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:28/11/2014

Actual:24/11/2014

Study start date

Planned:03/03/2015

Actual:06/02/2015

Date of interim report, if expected

Planned:29/05/2015

Actual:29/06/2015

Date of final study report

Planned:31/05/2018

Actual:07/05/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences Inc.

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)