| Ryzneuta (efbemalenograstim alpha) / Yifan Pharma |
Guard-02 study, ChiCTR2300078792: Efbemalenograstim alfa as primary prophylaxis for chemotherapy-induced neutropenia in breast cancer patients within 24 hours following chemotherapy: a prospective, multicenter, single-arm clinical study |
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| Not yet recruiting | 4 | 52 | | In the first EC chemotherapy cycle, subjects will receive efbemalenograstim α (20 mg, subcutaneous injection) 24 ± 4 hours after the end of chemotherapy administration. In all subsequent chemotherapy cycles, subjects will receive efbemalenograstim α 4 ± 1 hours (d1) after the end of chemotherapy administration. | Anhui Provincial Cancer Hospital; Anhui Provincial Cancer Hospital, Chia Tai Tianqing Pharmaceutical Group Co., Ltd | neutropenia | | | | |
Guard-06 trial, ChiCTR2400080573: Efficacy and safety of Efbemalenograstim alfa in preventing neutropenia induced by R-CHOP-like regimens in patients with newly diagnosed non-Hodgkin's lymphoma: A randomized controlled multicenter clinical study |
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| Not yet recruiting | 4 | 128 | | Subjects received efbemalenograstim alfa 20 mg/dose subcutaneously (SC) 48h (±4h) after receiving chemotherapy of each chemotherapy cycle.; Subjects received efbemalenograstim alfa 20 mg/dose subcutaneously (SC) 48h (±4h) after receiving chemotherapy of each chemotherapy cycle.; When the neutrophil count (ANC) of the subjects < 1.0×109/L, rhG-CSF 5μg/kg/d was given until the ANC≥5×109/L. Subjects with FN or dose-limiting neutropenia are allowed to use efbemalenograstim alfa for secondary prophylaxis. | Institute of Hematology & Oncology, Harbin First Hospital; Institute of Hematology & Oncology, Harbin First Hospital and Oncology, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Neutropenia | | | | |
Guard-01, ChiCTR2300077504: Efbemalenograstim alfa for primary prophylaxis of neutropenia in patients during concurrent chemoradiotherapy: a multicenter, prospective, randomized study |
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| Not yet recruiting | 4 | 120 | China | Subjects received efbemalenograstim alfa 20 mg/dose subcutaneously (SC) 48h (±4h) after receiving chemotherapy of each chemotherapy cycle.; When the neutrophil count (ANC) of the subjects < 1.0×10^9/L, rhG-CSF 5μg/kg/d was given until the ANC >= 5×10^9/L. Subjects with FN or dose-limiting neutropenia are allowed to use efbemalenograstim alfa for secondary prophylaxis. | Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Neutropenia | | | | |
NCT06143735: A Study of Efbemalenograstim Alfa Injection for Stage IIIB or IV NSCLC Recieving Moderate-risk Febrile Neutropenia (FN) Chemotherapy Regimen With Risk Factors |
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| Not yet recruiting | 2 | 99 | RoW | Efgbemalenograstim alfa | Tianjin Medical University Cancer Institute and Hospital, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Non Small Cell Lung Cancer | 12/24 | 06/26 | | |
NCT06251947: Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen |
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| Recruiting | 2 | 83 | RoW | Efbemalenograstim Alfa | Shandong University, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Ovarian Cancer, Cervical Cancer | 06/26 | 12/26 | | |
| Not yet recruiting | 1 | 24 | | | Nucleus Network, Generon (Shanghai) Corporation | Neutropenia | | | | |
EF-001, NCT06649448: A Multi-cohort Study of Efbemalenograstim Alfa Injection for Preventing ANC Reduction in Solid Tumor Patients Post Immune-chemotherapy. |
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| Not yet recruiting | N/A | 200 | RoW | Efbemalenograstim alfa Injection, carboplatin/cisplatin-etoposide, Carboplatin plus Paclitaxel, Cisplatin/pemetrexed or Carboplatin/pemetrexed, TP regimen | Shandong Cancer Hospital and Institute | Solid Tumor Cancer, Chemotherapy Induced Neutropenia, G-CSF | 12/25 | 05/26 | | |
