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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 4

Conditions: Severe Aplastic Anemia

Treatments: Drug: ATG

Study type: Interventional

Funder types: Other

Identifiers

NCT01997372

Xzhu

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

high dose ATG,low dose ATG

Experimental group

Treatment:

Drug: ATG