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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06004791
Other study ID # rHCsA
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date August 2023
Est. completion date August 31, 2025

Study information

Verified date August 2023
Source Peking Union Medical College Hospital
Contact Bing Han, Doctor
Phone +8601069151235
Email hanbing_li@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aplastic anemia (AA) is a group of clinical syndromes. Treatment options are very limited. The results of a previous clinical study showed good efficacy and a high safety profile of herombopag in improving thrombocytopenia, but this result needs to be supported by more data. In our study, patients who were willing to participate in this study and were diagnosed with transfusion-dependent non-heavy aplastic anemia were randomized to the rhTPO combined with herombopag + cyclosporine group and given rhTPO (at a dose of 1500 U by subcutaneous injection once daily for 7 d, 28 d for 3 courses) +Herombopag(10 mg/day for 3 months) + cyclosporine (3-5 mg/kg/d for 3 months). -5 mg/kg/d for at least 6 months) and herombopag + cyclosporine (10 mg/day for 3 months) + cyclosporine (3-5 mg/kg/d for at least 6 months) in the herombopag+ cyclosporine group to observe the efficacy and safety.


Description:

Aplastic anemia (AA) is a group of clinical syndromes caused by a significant decrease in bone marrow hematopoietic tissue from different etiologies, resulting in hematopoietic failure. The prevalence of AA in China is 7.4 per 1 million. It peaks in the 15-25 and 60+ age groups and is more common in men than women. Treatment options are very limited. The results of a previous clinical study showed good efficacy and a high safety profile of herombopag in improving thrombocytopenia, but this result needs to be supported by more data. In our study, patients who were willing to participate in this study and were diagnosed with transfusion-dependent non-heavy aplastic anemia were randomized to the rhTPO combined with herombopag + cyclosporine group and given rhTPO (at a dose of 1500 U by subcutaneous injection once daily for 7 d, 28 d for 3 courses) +Herombopag(10 mg/day for 3 months) + cyclosporine (3-5 mg/kg/d for 3 months). -5 mg/kg/d for at least 6 months) and Herombopag + cyclosporine (10 mg/day for 3 months) + cyclosporine (3-5 mg/kg/d for at least 6 months) in the herombopag+ cyclosporine group to observe the efficacy and safety.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date August 31, 2025
Est. primary completion date August 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. Age =18 years old. 2. Clearly diagnosed untreated NSAA. 3. At least one of the following conditions was met at the time of enrollment: hemoglobin <90 g/L. Platelet <30×109/L, neutrophils <1.0×109/L. 4. Baseline liver and kidney function (ALT, AST, Cr) was less than 2 times the normal value. 5. No active infection; Not pregnant or breastfeeding. 6. Agree to sign the consent form. 7. The Eastern Cancer Collaboration Group (ECOG) score was 0-2. Exclusion Criteria: 1. pancytopenia caused by other causes, such as myelodysplastic syndrome (MDS). 2. There is cytogenetic evidence of clonal hematologic bone marrow diseases (MDS, AML). 3. PNH clone =50%. 4. Had received hematopoietic stem cell transplantation (HSCT) before enrollment. 5. Immunosuppressive therapy such as ATG or cyclosporine use for more than 2 weeks. 6. Infection or bleeding that is not controlled by standard treatment. 7. Allergic to recombinant TPO or Hitrepopar. 8. Active HIV, HCV or HBV infection or cirrhosis or portal hypertension. 9. Any concomitant malignancy or local basal cell carcinoma of the skin within 5 years. 10. Previous history of thromboembolic events, heart attack or stroke (including antiphospholipid antibody syndrome) and current use of anticoagulants. 11. Women who are pregnant or nursing (lactation). 12. Have participated in other clinical trials within 3 months.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Herombopag + CsA
Herombopag(10mg/d)+CsA(3-5 mg/kg/d, adjust the grain concentration 100-200ng/ml)
rhTPO combined with Herombopag + CsA
rhTPO (15000U, subcutaneous injection, once a day for 7 days, once a month for 3 months),Herombopag(10mg/d)+CsA(3-5 mg/kg/d, adjust the grain concentration 100-200ng/ml)

Locations

Country Name City State
China Peking union medical college hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary ORR at 3 Months After 3 months of treatment, ORR was calculated by measuring platelets, hemoglobin, neutrophils, and transfusion independence Week 14
Primary ORR at 6 Months After 6 months of treatment, ORR was calculated by measuring platelets, hemoglobin, neutrophils, and transfusion independence Week 26
Secondary 3 months of drug safety Assessing the incidence and severity of adverse events; All adverse events that occur or worsen within 3 months of treatment will be reported Week 14
Secondary 6 months of drug safety Assessing the incidence and severity of adverse events; All adverse events that occur or worsen within 6 months of treatment will be reported Week 26
See also
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