Status:
COMPLETED
Hetrombopag or Placebo in Treatment-Naive Severe Aplastic Anemia
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Severe Aplastic Anemia
Eligibility:
All Genders
15-75 years
Phase:
PHASE3
Brief Summary
This is a multicenter, randomized, placebo-control, phase III study to investigate hetrombopag in subjects with severe AA who are treated naive. 180 treated naive patients with SAA will be enrolled i...
Eligibility Criteria
Inclusion
- 15 Years to 75 Years (weight greater than 50 kg if Age \< 18 years old). 2.Severe aplastic anemia characterized by Bone marrow cell proliferation less than 25 percent (If ≥25% but \<50%, the remaining hematopoietic cells should be \<30%) AND At least two of the following: Absolute neutrophil count \<0.5×109/L; Platelet count \<20×109/L; Absolute reticulocyte count \<20×109/L.
- Unsuitable or unwilling to perform hematopoietic stem cell transplantation (HSCT).
- Signed informed consent.
Exclusion
- Diagnosis of whole blood cell reduction due to other causes or bone marrow hypoproliferative diseases.
- Subjects who have previously received immunosuppressive therapy with mycophenolate mofetil, sirolimus, high dose cyclophosphamide (≥45mg/kg/d), alemtuzumab, etc；or have treated with thrombopoietin receptor agonist (eg, eltrombopag, romiplostim, rhTPO, etc.) prior to randomization.
- Previous history of hematopoietic stem cell transplantation.
- Subjects who is known or suspected of contraindications or hypersensitivity to Hetrombopag's API (Active Pharmaceutical Ingredient).
- Evidence of clonal cytogenetic abnormalities at the time of screening.
- Bleeding and/or Infection not adequately responding to appropriate therapy.
- Any laboratory or clinical evidence for HIV infection. Any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subjects screening.
- ALT\> 2.5 x upper limit of normal (ULN), AST\> 2.5 x upper limit of normal (ULN) DBLI\> 1.5 x upper limit of normal (ULN), Scr\> upper limit of normal (ULN).
- Subjects with uncontrolled hypertension (\>180/100mmHg), severe arrhythmia (such as complete left bundle branch block, QT interval prolongation (Bazetts formula), torsade ventricular tachycardia, etc.), unstable angina, pulmonary hypertension at the time of screening.
- Subjects diagnosed with cirrhosis or portal hypertension.
- Subjects with malignant solid tumors of any organ system within 5 years prior to screening, with or without treatment, metastasis or recurrence, except for local cutaneous basal cell carcinoma; subjects with hematological tumors found previously or during screening.
- Subjects with deep vein thrombosis, myocardial infarction, stroke or peripheral arterial embolization within 12 months prior to randomization.
- Female subjects who are nursing or pregnant.
- Subjects cannot comply with effective contraception.
- Subjects have participated in other clinical trial within the 3 months prior to study entry.
Key Trial Info
Start Date :
March 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2024
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03825744
Start Date
March 5 2019
End Date
July 3 2024
Last Update
November 7 2024
Active Locations (1)
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1
Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300041