ArticleTherapeutic advances in hematology2022
A multicenter phase II study on the efficacy and safety of hetrombopag in patients with severe aplastic anemia refractory to immunosuppressive therapy.
Article in Therapeutic advances in hematology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 23 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicentre, Open-label, Single-arm, Phase II Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Patients With Severe Aplastic Anemia
Avatrombopag in TPO-RA Refractory Aplastic Anemia Patients Safety and Efficacy Study --Single-arm, Multicenter, Open, Phase Π Clinical Study
Who cites it
23 citing papers in PubMed.
- Hetrombopag Added to Cyclosporine as the First-Line Treatment for Patients With Non-Severe Aplastic Anemia: A Phase 2 Multicenter Trial.American journal of hematology · 2026Trial
- Iron chelation of hetrombopag in aplastic anemia: a post hoc analysis of a phase II study.Annals of hematology · 2022Trial
- Advances and Clinical Applications of Thrombopoietic Agents.Current medical science · 2026Review
- Safety, pharmacokinetics, and preliminary efficacy of hetrombopag in pediatric patients with aplastic anemia: A pilot study.Annals of hematology · 2026Article
- Hematopoiesis could be improved by correcting aberrant bone marrow macrophages polarization in aplastic anemia patients.Science China. Life sciences · 2026Article
- Longitudinal clinical and preclinical studies identify hetrombopag as a potent chelator for systemic iron overload.HemaSphere · 2026Article
- [Efficacy and safety of romiplostim N01 for refractory aplastic anemia: a retrospective single-center study].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2026Article
- Hetrombopag for the treatment of chemotherapy-induced thrombocytopenia in patients with solid tumors.Research and practice in thrombosis and haemostasis · 2026Review
- Assessing serum thrombopoietin for enhanced diagnosis of ITP, AA, and MDS using machine learning: A retrospective cohort study.Annals of hematology · 2025Article
- Rapid early remission in a patient with severe aplastic anemia: a case report of hetrombopag, cyclosporine, and danazol combination therapy.Frontiers in immunology · 2025Article
- Hetrombopag treatment for immune thrombocytopenia in pregnancy refractory to corticosteroids and intravenous immunoglobulin: a case report.Frontiers in medicine · 2025Article
- The effect of hetrombopag combined with conventional treatment on immune function and quality of life in patients with severe aplastic anemia.Annals of hematology · 2024Article
- Efficacy and safety of hetrombopag in the treatment of recombinant human thrombopoietin-resistant thrombocytopenia after allogeneic hematopoietic stem cell transplantation.Research and practice in thrombosis and haemostasis · 2024Article
- Adding hetrombopag to cyclosporine a improved response of patients with newly diagnosed transfusion-dependent non-severe aplastic anemia.Annals of hematology · 2024Article
- Hetrombopag for the management of chemotherapy-induced thrombocytopenia in patients with advanced solid tumors: a multicenter, randomized, double-blind, placebo-controlled, phase II study.Therapeutic advances in medical oncology · 2024Article
- Hetrombopag plus recombinant human thrombopoietin for chemotherapy-induced thrombocytopenia in patients with solid tumors.Research and practice in thrombosis and haemostasis · 2023Article
- [Chinese expert consensus on the clinical application of recombinant human thrombopoiein and thrombopoiein receptor agonist (2023)].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2023Article
- Emerging data on thrombopoietin receptor agonists for management of chemotherapy-induced thrombocytopenia.Expert review of hematology · 2023Review
- Hetrombopag plus porcine ATG and cyclosporine for the treatment of aplastic anaemia: early outcomes of a prospective pilot study.Experimental hematology & oncology · 2023Article
- Antihuman T lymphocyte porcine immunoglobulin combined with cyclosporine as first-line immunosuppressive therapy for severe aplastic anemia in China: a large single-center, 10-year retrospective study.Therapeutic advances in hematology · 2023Article
Corrections and comments
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Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: In this single-arm phase II study (NCT03557099), we evaluated the efficacy and safety of hetrombopag, a small molecule thrombopoietin (TPO) receptor agonist, in patients with severe aplastic anemia (SAA) who were refractory to standard first-line immunosuppressive therapy (IST). Methods: SAA patients who were refractory to standard first-line IST were given hetrombopag orally at an initial dose of 7.5 mg once daily to a maximum of 15 mg once daily, for a total of 52 weeks. The primary endpoint was proportion of patients achieving hematologic responses in ⩾1 lineage at week 18. Results: A total of 55 eligible patients were enrolled and received hetrombopag treatment. This study met its primary endpoint, with 23 [41.8%, 95% confidence interval (CI) = 28.7-55.9] patients achieving hematologic response in ⩾1 lineage at week 18 after initiation of hetrombopag treatment. Twenty-four (43.6%, 95% CI = 30.3-57.7) and 27 (49.1%, 95% CI = 35.4-62.9) of the 55 patients responded in ⩾1 lineage at weeks 24 and 52, respectively. Median time to initial hematologic response was 7.9 weeks (range = 2.0-32.1). The responses were durable, with a 12-month relapse-free survival rate of 82.2% (95% CI = 62.2-92.2). Adverse events occurred in 54 (98.2%) patients, and 28 (50.9%) patients had treatment-related adverse events. Seventeen (30.9%) patients had adverse events of grade ⩾3. Serious adverse events occurred in 15 (27.3%) patients and three deaths (5.5%) were reported. Conclusion: Hetrombopag showed encouraging efficacy with durable hematologic responses in patients with SAA who were refractory to IST. Hetrombopag was well tolerant and safe for long-term use. ClinicalTrialsgov identifier: NCT03557099.
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