Registry of Pediatric Patients Treated with Vedrop® (Tocofersolan) in Europe for Vitamin E Deficiency due to Digestive Malabsorption in Congenital or Hereditary Chronic Cholestasis

Study identification

• EU PAS number:
  EUPAS11209
• Study ID:
  26087
• Official title and acronym:
  Registry of Pediatric Patients Treated with Vedrop® (Tocofersolan) in Europe for Vitamin E Deficiency due to Digestive Malabsorption in Congenital or Hereditary Chronic Cholestasis
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Netherlands

  Spain

  Sweden
• Study description:
  This study is conducted in Europe. The purpose of the study is to evaluate the safety and efficacy of tocofersolan (Vedrop) in pediatric patients suffering from vitamin E deficiency due to chronic or hereditary chronic cholestasis leading to digestive malabsorption.
• Study status:
  Finalised

Research institutions and networks

Institutions

Orphan Europe

Multilple centres: 8 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 20/07/2010

Study start date

Actual: 23/08/2010

Date of interim report, if expected

Actual: 05/10/2016

Date of final study report

Planned: 02/10/2017

Actual: 07/04/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Orphan Europe

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable