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pilot study of second line therapy for AAA Acquired Aplastic Anemia with antithymocyte globulin, cyclosporin and etanercept - ND

pilot study of second line therapy for AAA Acquired Aplastic Anemia with antithymocyte globulin, cyclosporin and etanercept - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-012746-23-IT
Enrollment
Unknown
Registered
2009-06-24
Start date
2009-05-12
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

acquired aplastic anemia MedDRA version: 9.1 Level: SOC Classification code 10005329

Interventions

Trade Name: ENBREL*SC 4FL 25MG+4SIR 1ML Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Etanercept Concentration unit: mg milligram(s) Concentration type: equal

Sponsors

ISTITUTO GIANNINA GASLINI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with SAA and VSAA with relapse of disease or no response after first line IS Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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: Pregnancy, availability of HLA compatible hematopoietic stem cell donor

Design outcomes

Primary

MeasureTime frame
Main Objective: to evaluate activity and safety of etanercept in association with IS therapy for AAA;Secondary Objective: evaluate hematological response;Primary end point(s): to evaluate activity and safety of etanercept in association with IS therapy—

Countries

Italy

Outcome results

None listed

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