Thalidomide, a novel immunological treatment to modify the natural history of paediatric Crohn's disease: a new proposal from a well-established paediatric research network - Talidomide in Crohn disease in Pediatrics

IRCCS Burlo Garofolo0 个研究点目标入组 124 人开始时间: 2016年11月30日最近更新: 2021年6月7日

适应症

试验速览

暂无简介。

•- Age at diagnosis between 6 and 18 years
•- New diagnosis of CD, defined on the basis of the Porto criteria after thus excluding infectious causes of enteritis.
•- No complicated CD (not stenosing not fistulizing) or not needing surgery for the treatment of simple perianal fistulizing disease.
•- Presence of at least one risk factor of negative prognosis (pernala fistulizing disease, panenteric disease, extention > 60 cm,
•severe growth retardation, severe osteoporosis, hypoalbuminemia or raised CRP (normal valuse x2)
•- Acceptance of contraceptive measures by patients in reproductive ages for reducing the risk of teratogenicity
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 124
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- infectious enteritis
•- Pregnancy in progress
•- Patients who are breast-feeding
•- Presence of peripheral neuropathy
•- Diagnosis of HIV
•- Diagnosis of tuberculosis
•- Diagnosis of Hepatitis HBV or HCV
•- other infections such as sepsis, abscesses, opportunistic infections in progress or other serious diseases not controlled.
•- Patients undergone treatment with a live vaccine during the 30 days prior to enrollment in the study.
•- Presence of moderate to severe heart failure (Class III / IV NYHA - New York Heart Association).
•- Patients with organ transplants
•- involvement in other clinical trials

发起方

IRCCS Burlo Garofolo