At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 35 enrolled
Drug / intervention
rabbit antithymocyte globulindrug
Likely dose
Rabbit ATG 1.5 vials/10 kg daily for 5 daysAI-extracted
Key inclusion· 5
- ✓Diagnosis of acquired aplastic anemia meeting criteria (at least two cytopenias + hypocellular marrow) or SAA (bone marrow <25% cellularity + neutrophil <0.5×10⁹/L or platelets <20×10⁹/L or reticulocytes <20×10⁹/L) or NSAA (hypocellular marrow, cytopenia in ≥2 cell lines, neutrophil >0.5×10⁹/L, transfusion dependence)
- ✓Acquired aplastic anemia (not inherited bone marrow failure syndromes)
- ✓Time from diagnosis to registration ≤6 months
- ✓Age ≥16 years, no upper age limit
Key exclusion· 9
- ✕For SAA patients: eligibility for HLA-matched sibling donor transplant
- ✕Prior therapy with ATG or ciclosporin
- ✕Haemopoietic growth factors >4 weeks before enrollment
- ✕Diagnosis of Fanconi anemia, dyskeratosis congenita, or congenital bone marrow failure syndrome
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia and Comparison With Matched Historical Patients Treated With Horse ATG and Ciclosporin
European Society for Blood and Marrow Transplantation·interventional·Posted May 10, 2007·Updated May 12, 2026
In Brief
A Phase 2 clinical trial evaluating rabbit antithymocyte globulin for Aplastic Anemia. Completed, enrolled 35 participants across 14 sites in 6 countries.
Detailed Summary
To assess the tolerability and effectiveness of rabbit antithymocyte globulin (ATG, Thymoglobuline) with ciclosporin in the first line treatment of patients with acquired severe aplastic anaemia, and patients with non-severe aplastic anaemia and who are transfusion dependent.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAplastic Anemia
CountriesFrance, Germany, Italy, Saudi Arabia, Switzerland, United Kingdom
CollaboratorsGenzyme, a Sanofi Company
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2007
Enrollment StartAug 2008
Primary CompletionOct 2011
Study CompletionFeb 2013
TodayJul 2026
First PostedMay 10, 2007
Enrollment StartAug 1, 2008
Primary CompletionOct 1, 2011
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 19.1 years ago
Interventions
rabbit antithymocyte globulindrug
1.5 vials/10kg daily for 5 days