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Superiority of a metformin hydrochloride combination regimen for aplastic anemia in a phase II clinical trial

Superiority of a metformin hydrochloride combination regimen for aplastic anemia in a phase II clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000028833
Enrollment
Unknown
Registered
2020-01-05
Start date
2020-01-01
Completion date
Unknown
Last updated
2020-01-06

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

Conditions

Acquired aplastic anemia

Interventions

Control group:HSCT/ATG
Experimental group:Combined regimen with metformin hydrochloride

Sponsors

Department of Hematology, Second Medical Center, Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
14 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male or female aged >14 years; 2. Patients confirmed by clinical tests as refractory acquired aplastic anemia; 3. Have received formal treatment, including cyclosporine A (CsA), anti-human thymosin and anti-human lymphocyte globulin (ATG / ALG), androgens; 4. The treatment effect is not good, that is, according to the evaluation standard of effectiveness (Yang Chongli, Shao Zonghong. Aplastic Anemia [M] Zhang Zhinan, Shen Yan. Hematological diagnosis and efficacy standards. Version 3. Beijing: Science Press, 2007) Diagnosed as invalid or disease progression; 5. ECOG physical status score 0 to 2 points; 6. Have not participated in other clinical trials within four weeks; 7. Clinicians believe that patients do not need to initiate clinical treatment immediately.

Exclusion criteria

Exclusion criteria: 1. Suffering from other diseases that may cause whole blood cell decline and low bone marrow hematopoiesis, such as myelodysplastic syndrome (MDS), malignant blood tumors, paroxysmal nocturnal hemoglobinuria (PNH), nutritional anemia, immunity Thrombocytopenic purpura (ITP), autoimmune disease; 2. Are receiving other therapies (conflicts with this trial protocol); 3. Allergic to drugs that may be used; 4. Any medical history or concomitant disease that any investigator believes may reduce patient compliance, or interfere with the evaluation of the efficacy and safety of the test drug; 5. Major surgery will be performed within 4 weeks before the start of study treatment, or surgery will be scheduled during the study.

Design outcomes

Primary

MeasureTime frame
HB;PLT;ANC;RC;

Countries

China

Contacts

Public ContactXuechun Lu

Department of Hematology, Second Medical Center, Chinese PLA General Hospital

luxuechun@126.com+86 13241892863

Outcome results

None listed

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