9 not yet recruiting, 9 recruiting, 2 withdrawn, 1 unknown. 14 Phase 2, 3 Not applicable, 3 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 14 | Not yet recruiting 6, Recruiting 6, Withdrawn 2 |
| Not applicable | 3 | Not yet recruiting 2, Recruiting 1 |
| Phase 3 | 3 | Not yet recruiting 1, Recruiting 1, Unknown 1 |
| Phase 1 | 1 | Recruiting 1 |
Follow Romiplostim N01: new trials by email Literature Review of Romiplostim N01 trials Research Report on Romiplostim N01
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy and Safety of Romiplostim N01 for Injection in Promoting Platelet Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation Romiplostim N01 - Thrombocytopenia, Allogeneic Hematopoietic Stem Cell Transplantation | Phase 2 | Not yet recruiting | The First Affiliated Hospital of Henan University of Science and Technology | 87 | 2026-11-01 | 2026-09-21 |
| Romiplostim N01 for Injection for Secondary Prophylaxis of CIT in Breast Cancer Romiplostim N01 - Thrombocytopenia Chemotherapy Induced | Phase 2 | Not yet recruiting | Fudan University | 53 | 2026-08-01 | 2026-08-18 |
| Romiplostim N01 in the Treatment of Refractory Chemoradiotherapy-induced AA Romiplostim N01 - Aplastic Anemia | Phase 2 | Withdrawn | Peking Union Medical College Hospital | 2026-06-01 | 2026-06-04 | |
| CsA+EPAG/HPAG+Romiplostim N01 in the Treatment of Newly-diagnosed SAA/TD-NSAA Cyclosporine (CsA), Thrombopoietin Receptor Agonist, Romiplostim N01 - Severe Aplastic Anemia (SAA), Transfusion-dependent Non-severe Aplastic Anemia | Phase 2 | Withdrawn | Peking Union Medical College Hospital | 2026-06-01 | 2026-06-04 | |
| Phase II Study of Orelabrutinib in Combination With Romiplostim N01 in Patients With Primary Immune Thrombocytopenia (ITP) Who Have Received At Least One Prior Line of Therapy Orelabrutinib, Romiplostim N01 - Primary Immune Thrombocytopenia (ITP) | Phase 2 | Not yet recruiting | Peking Union Medical College Hospital | 28 | 2026-04-01 | 2026-02-10 |
| Romiplostim N01 in Chemoradiotherapy-induced Aplastic Anemia Romiplostim N01 - Aplastic Anemia | Phase 2 | Not yet recruiting | Peking Union Medical College Hospital | 43 | 2026-04-01 | 2026-05-07 |
| CsA+EPAG/HPAG+Romiplostim N01 in Newly-diagnosed SAA/TD-NSAA Cyclosporine (CsA), thrombopoietin receptor agonist (TPO-RA), Romiplostim N01 - Severe Aplastic Anemia (SAA), Transfusion-dependent Non-severe Aplastic Anemia | Phase 2 | Not yet recruiting | Peking Union Medical College Hospital | 43 | 2026-04-01 | 2026-04-30 |
| A Study of Romiplostim N01 Plus IST vs. Placebo Plus IST for Treatment-Naive Severe Aplastic Anemia Romiplostim N01, Cyclosporine A (CsA), pALG/ rATG - Treatment-naïve Severe Aplastic Anemia | Phase 3 | Not yet recruiting | Qilu Pharmaceutical Co., Ltd. | 210 | 2026-01-01 | 2026-01-15 |
| Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia in Pediatric Cancer Patients Romiplostim N01 - Solid Tumors, Hematological Tumor | Phase 2 | Recruiting | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | 50 | 2025-12-25 | 2026-05-07 |
| Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gastrointestinal Solid Tumors Romiplostim N01, All-trans retinoic acid - Persistent Isolated Chemotherapy-Induced Thrombocytopenia, Chemotherapy-Induced Thrombocytopenia | Phase 2 | Recruiting | Peking University People's Hospital | 220 | 2025-12-22 | 2026-05-14 |
| Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gynecologic, Breast, or Lung Solid Tumors Romiplostim N01, All-trans retinoic acid - Persistent Isolated Chemotherapy-Induced Thrombocytopenia, Chemotherapy-Induced Thrombocytopenia | Phase 2 | Recruiting | Peking University People's Hospital | 220 | 2025-12-22 | 2026-05-14 |
| Romiplostim N01 in the Treatment of Thrombocytopenia Caused by Cytotoxic Drugs in Breast Cancer Patients romiplostim N01 - Cytotoxic Drugs, Romiplostim N01 | Not applicable | Not yet recruiting | Tianjin Medical University Cancer Institute and Hospital | 68 | 2025-09-20 | 2025-09-09 |
| Romiplostim N01 for the Treatment of Thrombocytopenia Associated With Radiotherapy-Combined Treatment Regimens in Patients With Solid Tumors Romiplostim N01 - Solid Tumors | Phase 2 | Not yet recruiting | Zhujiang Hospital | 60 | 2025-09-15 | 2025-09-04 |
| Efficacy and Safety of Romiplostim N01 Combined With Rituximab in Patients With Oral TPO-RA-Refractory Primary Immune Thrombocytopenia Romiplostim N01, Rituximab - Primacy Immune Thrombocytopenia | Not applicable | Recruiting | The First Affiliated Hospital of Soochow University | 30 | 2025-09-01 | 2025-12-04 |
| A Multicenter, Open-label, Randomized Controlled Trial Evaluating the Efficacy and Safety of Romiplostim N01 in the Treatment of Thrombocytopenia Associated With Concurrent/Sequential Chemoradiotherapy and Chemotherapy Combined With/Without Immunotherapy in Solid Tumors Human Interleukin-11, Romiplostim N01 - Solid Tumor Malignancies, Cancer, CTIT-Chemotherapy Induced Thrombocytopenia | Not applicable | Not yet recruiting | Jun wang | 106 | 2025-09-01 | 2025-09-22 |
| Romiplostim N01 for Chemotherapy-induced Thrombocytopenia Romiplostim N01 - Chemotherapy-induced Thrombocytopenia, Romiplostim N01 | Phase 2 | Recruiting | Institute of Hematology & Blood Diseases Hospital, China | 50 | 2025-08-01 | 2025-07-14 |
| Efficacy and Safety Study of Romiplostim N01 for Cancer Treatment-induced Thrombocytopenia (CTIT) in the Treatment of Leukemia Romiplostim N01 - Cancer Treatment-induced Thrombocytopenia (CTIT) | Phase 2 | Recruiting | Anhui Provincial Hospital | 97 | 2025-07-14 | 2026-08-24 |
| Romiplostim N01 for Platelet Recovery After Haploidentical HSCT Romiplostim N01, Standard Supportive Care - Acute Myeloid Leukemia, MDS (Myelodysplastic Syndrome) | Phase 1 | Recruiting | First Affiliated Hospital of Zhejiang University | 130 | 2025-06-01 | 2026-01-28 |
| A Study on the Treatment of CTIT of the Efficacy and Safety With Romiplostim N01 Compared to Recombinant Human Interleukin-11 Romiplostim N01, Recombinant Human Interleukin-11 (rhIL-11) - CTIT: Cancer Therapy Induced Thrombocytopenia | Phase 3 | Recruiting | The First Affiliated Hospital with Nanjing Medical University | 88 | 2025-02-24 | 2026-04-14 |
| Romiplostim N01 for Platelet Recovery in Adult Hematologic Malignancies Patients Undergoing UCBT Romiplostim N01 - Platelet Recovery After Umbilical Cord Blood Transplantation | Phase 2 | Recruiting | Anhui Provincial Hospital | 34 | 2024-12-01 | 2024-11-18 |
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Anemia, Aplastic (4) · Thrombocytopenia (4) · Breast Neoplasms (2) · Pathologic Complete Response (2) · Anemia, Refractory, with Excess of Blasts (1) · Carcinoma, Non-Small-Cell Lung (1) · Colorectal Neoplasms (1) · Digestive System Neoplasms (1) · Endometrial Neoplasms (1) · Fallopian Tube Neoplasms (1) · Gastrointestinal Neoplasms (1) · Hematologic Neoplasms (1) · Leukemia, Myeloid, Acute (1) · Lung Neoplasms (1) · Neoplasms (1)
Peking Union Medical College Hospital (5) · Anhui Provincial Hospital (2) · Peking University People's Hospital (2) · Cancer Institute and Hospital, Chinese Academy of Medical Sciences (1) · First Affiliated Hospital of Zhejiang University (1) · Fudan University (1) · Institute of Hematology & Blood Diseases Hospital, China (1) · Jun wang (1) · Qilu Pharmaceutical Co., Ltd. (1) · Shandong University (1) · The First Affiliated Hospital of Henan University of Science and Technology (1) · The First Affiliated Hospital of Soochow University (1) · The First Affiliated Hospital with Nanjing Medical University (1) · Tianjin Medical University Cancer Institute and Hospital (1) · Zhujiang Hospital (1)
China (13)
Xiaohui Zhang, MD (2) · Sidan Li (1) · Tienan Zhu, M.D. (1) · Xiaoyu Zhu, Ph.D (1) · Yunfei Chen, MD (1)