A 6-thioguanine (6-TG) registry that explores the effectiveness and safety of 6-TG in the long-term treatment of inflammatory bowel disease (IBD)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40856
• EU PAS number:
  EUPAS13007
• Study ID:
  40856
• Official title and acronym:
  A 6-thioguanine (6-TG) registry that explores the effectiveness and safety of 6-TG in the long-term treatment of inflammatory bowel disease (IBD)
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  Thiosix has been granted conditional approval by the regulatory authorities of the Netherlands. One of the conditions under which this approval was granted was to conduct a study that would further support the long-term efficacy and safety in a maintenance indication. Monitoring of all types of safety aspects by prospectively following-up patients using Thiosix is the objective of this study. The incidence of clinically confirmed NRH is the main concern and therefore the primary objective of this study.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amsterdam UMC

AUMC Netherlands, Maxima MC Netherlands, UMC Groningen Netherlands, UMC Utrecht Netherlands, Radboud UMC Netherlands, Meander MC Netherlands, Maasstad Netherlands, Isala Netherlands

Study timelines

Date when funding contract was signed

Actual: 26/02/2016

Study start date

Planned: 01/04/2016

Actual: 12/05/2016

Data analysis start date

Actual: 14/12/2020

Date of interim report, if expected

Actual: 22/12/2017

Date of final study report

Planned: 01/05/2021

Actual: 01/05/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Teva Nederland BV

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)