Anti-TNF monoclonal antibody to treat acute GvHD refractary to the first line therapy with steroids - ND
- Conditions
- Anti-TNF monoclonal antibody to treat acute GvHD refractary to the first line therapy with steroidsMedDRA version: 9.1Level: LLTClassification code 10010162Term: Complications of bone marrow transplant
- Registration Number
- EUCTR2008-006726-34-IT
- Lead Sponsor
- ISTITUTO GIANNINA GASLINI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
patients between 0 and 18 years underwent allogeneic HSCT who developed acute GvHD not responsive to steroid therapy given at dosage of 2mg/Kg/day
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
patients with previous or actual tubercolosis.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate the safety and toxicity of etanercept at short and long term;Secondary Objective: to evaluate the efficacy of etanercept at short and long term;Primary end point(s): to evaluate the safety and toxicity of etanercept at short and long term
- Secondary Outcome Measures
Name Time Method