Status:
UNKNOWN
A Prospective, Randomized, Controlled Study of rhTPO in Combination With Herombopag + CsA vs Herombopag + CsA for the Treatment of Primary TD-NSAA
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Aplastic Anemia
Drug Effect
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief 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 impr...
Detailed 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...
Eligibility Criteria
Inclusion
- Age ≥18 years old.
- Clearly diagnosed untreated NSAA.
- 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.
- Baseline liver and kidney function (ALT, AST, Cr) was less than 2 times the normal value.
- No active infection; Not pregnant or breastfeeding.
- Agree to sign the consent form.
- The Eastern Cancer Collaboration Group (ECOG) score was 0-2.
Exclusion
- pancytopenia caused by other causes, such as myelodysplastic syndrome (MDS).
- There is cytogenetic evidence of clonal hematologic bone marrow diseases (MDS, AML).
- PNH clone ≥50%.
- Had received hematopoietic stem cell transplantation (HSCT) before enrollment.
- Immunosuppressive therapy such as ATG or cyclosporine use for more than 2 weeks.
- Infection or bleeding that is not controlled by standard treatment.
- Allergic to recombinant TPO or Hitrepopar.
- Active HIV, HCV or HBV infection or cirrhosis or portal hypertension.
- Any concomitant malignancy or local basal cell carcinoma of the skin within 5 years.
- Previous history of thromboembolic events, heart attack or stroke (including antiphospholipid antibody syndrome) and current use of anticoagulants.
- Women who are pregnant or nursing (lactation).
- Have participated in other clinical trials within 3 months.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06004791
Start Date
August 1 2023
End Date
August 31 2025
Last Update
August 22 2023
Active Locations (1)
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1
Peking union medical college hospital
Beijing, China