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A Prospective Randomized Controlled Study on Hematopoietic Reconstitution after Allogeneic Hematopoietic Stem Cell Transplantation in Patients with Severe Aplastic Anemia

A Prospective Randomized Controlled Study on Hematopoietic Reconstitution after Allogeneic Hematopoietic Stem Cell Transplantation in Patients with Severe Aplastic Anemia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091592
Enrollment
Unknown
Registered
2024-10-30
Start date
2024-03-05
Completion date
Unknown
Last updated
2024-11-04

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

Conditions

severe aplastic anemia undergoing allogeneic hematopoietic stem cell transplantation

Interventions

The control group was treated with triambutol:Patients were treated with the same drugs as in the HTP group, except that rhTPO and TPO-RA were not used.
Haiqu Popa Formation:Haiqu Popa

Sponsors

Suzhou Hongci Blood Disease Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 12-65, regardless of gender; 2. Patients with severe aplastic anemia undergoing allogeneic hematopoietic stem cell transplantation. 3. ECOG score 0-3; 4. The patient or his/her guardian must be able to understand and be willing to participate in the study and sign the informed consent form; 5. Total bilirubin = 10 times the upper limit of normal and serum creatinine = 1.5 times the upper limit of normal at the start of the study; 6. negative for serum human immunodeficiency virus (HIV) antigen or antibody. 7. Hepatitis C virus (HCV) antibody negative, or HCV antibody positive but HCV-RNA negative; 8. Hepatitis B virus (HBV) surface antigen and core antibody are both negative. If any of them is positive, the quantity of HBV-DNA in peripheral blood should be less than 1 * 10E2IU/ml.

Exclusion criteria

Exclusion criteria: 1. Abnormal liver and kidney function: creatinine level = 177 umol/L (1.5mg/DL), transaminase and bilirubin levels significantly increased (3 times or more higher than the upper limit of normal). 2. Clinically uncontrolled active infections (including bacterial, viral or fungal infections), but patients under effective drug treatment are not excluded; 3. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis, viral infection, active hepatitis B/C; when HBsAg and HBcAg are positive, HBV-DNA positive patients should be excluded, and negative patients can enter this clinical trial; HCV-RNA positive hepatitis C patients are excluded). Patients with chronic hepatitis B and albumin level < 3.5g/dL, or ESLD score = 10. 4. Critically ill or complicated by severe liver, kidney, heart, nerve, lung, infectious or metabolic diseases, the patient may not be able to tolerate the treatment plan or may die within 7-10 days. 5. Pregnant or lactating women. 6. Suffering from mental disorders and unable to cooperate with the requirements of treatment and monitoring. 7. Severe cataract. 8. Hypersensitivity to Hydrotripopa. 9. Malignant tumors of other organs at the same time. 10. Those who are conducting clinical trials of other drugs. 11. The patient is unable to understand or comply with the study protocol. 12. The investigator determines that the patient has other reasons for not being eligible to participate in the study, or that participation in the study would pose a significant risk to the patient.

Design outcomes

Primary

MeasureTime frame
Platelets;HB;neutrophil;

Secondary

MeasureTime frame
Platelet and red blood cell transfusion;Whether there is bleeding, the frequency of bleeding and the severity of bleeding;Whether there was secondary erythrocytopenia and thrombocytopenia during the follow-up period.;Treatment-related side effects;

Countries

China

Contacts

Public ContactLimin Liu

Suzhou Hongci Blood Disease Hospital

liminliu2006@163.com+86 512 80668069

Outcome results

None listed

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