No registrations found.
ID
Source
Brief title
Health condition
IBD patients, inadequately responding (lack of response and/or intolerance) to standard thiopurine therapy
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Monitor the incidence of NRH in IBD patients using 6-thioguanine as Thiosix
Secondary outcome
• Examine the safety of treatment with 6-thioguanine, as Thiosix, for 1 year or longer in IBD patients
• Follow-up on long-term efficacy of 6-TG (Thiosix) treatment in IBD patients
Background summary
• Monitoring of the incidence of NRH in IBD patients using 6-thioguanine as Thiosix
• Examine the safety of treatment with 6-thioguanine, as Thiosix, for 1 year or longer in IBD patients
• Follow-up on long-term efficacy of 6- thioguanine treatment in IBD patients
• Monitoring of patient reported outcomes (PRO)
Study objective
Patients will remain in clinical remission after switch to Thiosix
Study design
Safety of Thiosix within at least one year follow up
Inclusion criteria
1. IBD diagnosis, according to current ECCO guidelines for at least 3 months (UC is characterised by diffuse mucosal inflammation limited to the colon; CD is characterised by patchy, transmural inflammation which may affect any part of GI tract).
2. Currently using 6-TG and willing to switch to Thiosix formulation.
3. The subject must have signed the ICF voluntarily before data is entered in the study database, after having been informed about the purpose of the study and by whom and in what way his/her medical and treatment data will be used.
Exclusion criteria
1. Patients younger than 18 years
2. Breastfeeding women
3. Previously demonstrated clinically significant allergy or hypersensitivity to the study drug or to any of the excipients of the medication.
4. Patients using 6-TG in another formulation than Thiosix
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7572 |
| Other | METc VUmc : 2016.182 |