Efficacy and safety of thalidomide in pediatric patients with Crohn's disease

Phase 1

• Conditions: Crohn's Disease; MedDRA version: 19.0Level: LLTClassification code 10011402Term: Crohn's disease (colon)System Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-000786-24-IT
• Lead Sponsor: IRCCS Burlo Garofolo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-30
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified