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Randomized, parallel controlled study for the efficacy and safety of different doses of CyA in the treatment of aplastic anemia

Randomized, parallel controlled study for the efficacy and safety of different doses of CyA in the treatment of aplastic anemia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003833
Enrollment
Unknown
Registered
2013-09-07
Start date
2013-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Aplastic anemia

Interventions

1:CSA 3mg/kg/d, for three years
2:CSA 5mg/kg/d, for three years

Sponsors

General Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) aged 14-70 years confirmed by first treated acquired AA patients; (2) in unconditional for HLA sibling donor hematopoietic stem cell transplantation; (3) economic ability accept ATG + CsA standard immunosuppressive therapy; (4) the blood biochemical indexes: ALT and AST is normal, normal serum bilirubin level, urea nitrogen, creatinine, normal electrolyte normal or after treatment to normal; (5) subject to the consent and have signed the CSA in the treatment of informed consent.

Exclusion criteria

Exclusion criteria: (1) active visceral bleeding; (2) Severe infection, after active treatment can't control; (3) abnormal cardiac function evaluation; (4) during pregnancy and lactation women; (5) childbearing age women not to take effective contraceptive measures; (6) researchers think unsuitable to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
Fasting blood concentration of CSA;Blood concentration of CSA of 2 hours after taking the drug;Consumption of CSA per kilogram per day;The frequency of taking drug per day;The cycles of taking the drug at the time of detecting concentration of CSA;Species of CSA;Age;Sex;Liver and kidney function;Treatment effect;Whether still need infusion of blood products;Rising quantity of hemoglobin;Neutrophils absolute value;Platelet count;Recovery time of blood count;Proliferation activity of sternum and iliac bone marrow;The number of megakaryocyte of sternum and iliac bone marrow;Anti-body of bone marrow cell membrane;

Countries

China

Contacts

Public ContactZonghong Shao

General Hospital of Tianjin Medical University

shaozonghong@sina.com+86 13802036467

Outcome results

None listed

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