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Efficacy of Danazol after no response to cyclosporin in transfusion independent aplastic anemia: a prospective study

Efficacy of Danazol after no response to cyclosporin in transfusion independent aplastic anemia: a prospective study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041485
Enrollment
Unknown
Registered
2020-12-27
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-03-15

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

Conditions

transfusion independent aplastic anemia

Interventions

experimental group:Cyclosporine combined with danazol
control group:Cyclosporine

Sponsors

Institute of Hematology & Hospital of Blood Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Aged > 14 years. 2) Aplastic anemia is clearly diagnosed from the peripheral blood smear and bone marrow examination. 3) Transfusion independence with ANC > 0.5 x 10^9/L. 4) Never received immunosuppressive therapy(IST) before or received IST less than 4weeks. 5) Never received androgen therapy before or received androgen therapy less than 4weeks. 6) Can fully understand and voluntarily sign informed consent forms.

Exclusion criteria

Exclusion criteria: 1) Aplastic anemia patients with PNH clones. 2) Diagnosed with congenital aplastic anemia or other congenital bone marrow failure. 3) Patients with abnormal liver function, i.e. ALT or AST > 2.5ULN, or TB > 2ULN, or CrCl < 60 ml/min/1.73 m^2. 4) Experienced a solid tumor or received radiation therapy/chemotherapy. 5) Nursing women. 6) Inability to understand or to follow study procedures.

Design outcomes

Primary

MeasureTime frame
superior remission rate;

Secondary

MeasureTime frame
rate of progression;relapse rate;

Countries

China

Contacts

Public ContactShi Jun

Institute of Hematology & Hospital of Blood Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College

shijun@ihcams.ac.cn+86 13752253515

Outcome results

None listed

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