Title Cerebrotendinous Xanthomatosis Registry: Long term Non-Interventional Follow-up of Safety and Effectiveness of Chenodeoxycholic Acid Leadiant.

Study identification

• EU PAS number:
  EUPAS27028
• Study ID:
  46836
• Official title and acronym:
  Title Cerebrotendinous Xanthomatosis Registry: Long term Non-Interventional Follow-up of Safety and Effectiveness of Chenodeoxycholic Acid Leadiant.
• DARWIN EU® study:
  No
• Study countries:
  France

  Italy

  Netherlands

  United Kingdom
• Study description:
  Research question and objectives The objective of the registry study is to collect long-term safety and effectiveness of Chenodeoxycholic Acid Leadiant in the treatment of Cerebrotendinous Xanthomatosis.
• Study status:
  Ongoing

Research institutions and networks

Institutions

CWZ Nijmegen

Study timelines

Date when funding contract was signed

Planned:14/12/2017

Actual:19/10/2017

Study start date

Planned:15/12/2019

Actual:09/03/2020

Date of interim report, if expected

Planned:15/03/2023

Date of final study report

Planned:30/03/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Leadiant Biosciences Ltd

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 2 (specific obligation of marketing authorisation)