Different Doses of Anti-thymocyte Globin to Treat Child Severe Aplastic Anemia

Different Doses of Anti-thymocyte Globin With 2.5 or 3.75mg/kg to Treat Child Severe Aplastic Anemia

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01997372

Enrollment

100

Registered

2013-11-28

Start date

2010-12-31

Completion date

2015-11-30

Last updated

2013-12-03

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

Conditions

Severe Aplastic Anemia

Keywords

ATG, SAA, immunosuppressive treatment, cyclosporine

Brief summary

Severe acquired aplastic anaemia (SAA) is a life-threatening disease characterized by pancytopenia and hypoplastic bone marrow. Immunosuppressive treatment with antithymocyte globulin (ATG)and cyclosporine remain the standard regimen with response rates of 70% or more and excellent overall survival. However ,there are no clinical trials to illustrate the response and complete remission rate with different doses of ATG.And there are no data reported on children with SAA so far.

Interventions

DRUGATG

Drug ATG:2.5mg/kg/d or 3.75mg/kg/d for 5 days; Drug Cyclosporine A (CSA):3-10mg/kg/d ,Adjust the dose to maintain drug levels between 150 and 300ng/ml; Drug prednisone:1mg/kg/d,d1-21 from the first dosage of ATG; Drug Granulocyte Colony-Stimulating Factor(G-CSF):5ug/kg/d until absolute neutrophil count (ANC) \>1×109/L.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

Healthy volunteers

Inclusion criteria

* clinical diagnosis of childhood acquired severe aplastic anemia(SAA)

Exclusion criteria

* clinical diagnosis of no childhood acquired severe aplastic anemia(SAA)

Design outcomes

Primary

Measure	Time frame	Description
the response and complete remission rate with different doses of ATG to treat child severe aplastic anemia	1 years	Complete response (CR) was defined as achieving normal levels of hemoglobin adjusted for age, platelet count \>100×109/L, and ANC\>1.5×109/L. Partial response (PR) was defined as transfusion independence, reticulocyte count \>30×109/L, platelet count \>20×109/L, and ANC \>0.5×109/L above the baseline. Persistence of transfusion requirement or death was evidence of no response (NR).

Secondary

Measure	Time frame	Description
the relapse rate with different doses of ATG to treat child severe aplastic anemia	4-10 years	relapse was defined as transfusion dependence again; or progressed to paroxysmal nocturnal hemoglobinuria (PNH) /acute myeloid leukemia/myelodysplasia syndrome (MDS); or CSA dependence

Countries

China

Contacts

Primary ContactXiaofan Zhu, MD

zhuxiaof@yahoo.com.cn+86 22 23909001

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026