European VOD Registry

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03032016
• Date of registration: 24/01/2017
• Prospective Registration: No
• Primary sponsor: Jazz Pharmaceuticals
• Public title: European VOD Registry
• Scientific title: A Multi-centre, Multinational, Prospective Observational Registry to Collect Safety and Outcome Data in Patients Diagnosed With Severe Hepatic Veno-occlusive Disease (VOD) Following Hematopoietic Stem Cell Transplantation (HSCT) and Treated With Defitelio®
• Date of first enrolment: April 24, 2015
• Target sample size: 176
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03032016
• Study type: Observational

Countries of recruitment

France, Ireland, Italy, Portugal, United Kingdom

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients undergoing hematopoietic stem cell transplantation and diagnosed with severe
hepatic VOD, who agree to participate in the study (Main population).

- Patients treated with defibrotide for another condition than severe hepatic VOD
(Secondary population) in the scope of hematopoietic stem cell transplantation .

Exclusion Criteria:

- There will not be any specific exclusion criteria; however contraindications, special
warnings and precautions for use as detailed in the SPC will have to be considered by
the treating physician.



Age minimum: 1 Month
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hepatic Veno-Occlusive Disease

Primary Outcome(s)

Incidence rate of specific SAE of interest [Time Frame: over 12 months]

Secondary Outcome(s)

Describe the population treated [Time Frame: Enrolment]

GvHD incidence [Time Frame: over 12 months]

VOD/MOF Resolution [Time Frame: over 12 months]

Survival [Time Frame: over 12 months]

Secondary ID(s)

DF VOD-2013-03-REG

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

European Group for Blood and Marrow Transplantation