EUCTR2008-003368-21-IT
Active, not recruiting
Not Applicable
Pilot trial of CTLA4-Ig (Abatacept) in a child affected by a severe congenital autoimmune syndrome (IPEX) - Trial of Abatacept in IPEX syndrome
ISTITUTO PER L`INFANZIA BURLO GAROFOLO0 sitesFebruary 6, 2009
ConditionsFor patients with a stabilized clinical condition, not recovered in care units for acute problems.MedDRA version: 9.1Level: HLGTClassification code 10003816MedDRA version: 9.1Level: HLTClassification code 10027657
DrugsORENCIA
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- For patients with a stabilized clinical condition, not recovered in care units for acute problems.
- Sponsor
- ISTITUTO PER L`INFANZIA BURLO GAROFOLO
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Confirmed diagnosis of IPEX. Unfavourable cost/benefit ratio for Hematopoietic Stem Cell Transplantation. In particular: 1\)patients who already developed autoimmune disorders and/or organ failure because of the disease 2\)disease not fully controlled by an intensive treatment at doses of conventional immunosuppressants producing severe side effects (infections, adrenal\-hypotalamic suppression).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •Positivity for mycobacterius tuberculosis infection.
Outcomes
Primary Outcomes
Not specified
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