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Anti-TNF monoclonal antibody to treat acute GvHD refractary to the first line therapy with steroids - ND

Anti-TNF monoclonal antibody to treat acute GvHD refractary to the first line therapy with steroids - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-006726-34-IT
Enrollment
Unknown
Registered
2009-03-17
Start date
2009-02-23
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-TNF monoclonal antibody to treat acute GvHD refractary to the first line therapy with steroids MedDRA version: 9.1 Level: LLT Classification code 10010162 Term: Complications of bone marrow transplant

Interventions

Trade Name: ENBREL Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: ETANERCEPT Other descriptive name: etanercept Concentration unit: mg/ml milligram(s)/millili

Sponsors

ISTITUTO GIANNINA GASLINI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: patients with previous or actual tubercolosis.

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026