EUCTR2014-001169-28-FR
Active, not recruiting
Phase 1
Traitement précoce de patients pédiatriques présentant un syndrome hémolytique et urémique typique par l’anticorps monoclonal anti-C5 eculizumab : essai thérapeutique prospectif randomisé contrôlé contre placebo de phase III
Centre Hospitalier de Toulouse0 sites100 target enrollmentJuly 31, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hemolytic and uremic syndrome
- Sponsor
- Centre Hospitalier de Toulouse
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pediatric patient (1 month\-18 years old)
- •. Affected by STEC\-HUS defined by:
- •\- Thrombocytopenia (\<150 000/mm3\)
- •\- Mechanic hemolytic anemia (Hemoglobin \< 10g/dL, haptoglobin ULN and/or bilirubine \>ULN, presence of schizocytes)
- •\- ARF defined by an estimated Schwartz 2009 creatinin clairance \<75ml/min/1,73m²
- •\- With prodromal diarrhea and/or presence of an enterohemorragic strain of Escherichia Coli and/or identification of the Stx 1 or 2 genes in the stool sample or rectal swab
- •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
Exclusion Criteria
- •. Neonatal HUS
- •. Malignancy
- •. Known HIV infection
- •. Pregnancy or lactation
- •. Identified drug exposure\-related HUS
- •. Infection\-related HUS
- •. Known systemic lupus erythematosus or antiphospholid antibody positivity or syndrome
- •. Patient already enrolled in a drug trial
- •. Patient with ongoing meningococcal infection
- •. Patient affected by aHUS or family history of aHUS
Outcomes
Primary Outcomes
Not specified
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