CLINICAL TRIALS PROFILE FOR ROMIPLOSTIM
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Biosimilar Clinical Trials for romiplostim
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT05621330 ↗ | Efficacy and Safety of QL0911 in Adult Patients With Chronic Primary Immune Thrombocytopenia: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Trial | Completed | Qilu Pharmaceutical Co., Ltd. | Phase 3 | 2019-10-18 | QL0911, a recombinant human thrombopoietin mimetic peptide-Fc fusion protein for injection, is a romiplostim (Nplate®) biosimilar for the treatment of primary immune thrombocytopenia (ITP). This phase III study aimed to assess the efficacy and safety of QL0911 in adults' patients with primary chronic ITP during a 24-week treatment period. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for romiplostim
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00111475 ↗ | Evaluating the Safety and Efficacy of Romiplostim (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP) | Completed | Amgen | Phase 2 | 2002-07-01 | The primary objective of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with ITP. |
| NCT00117143 ↗ | Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP) | Completed | Amgen | Phase 1/Phase 2 | 2002-12-02 | The purpose of this study is to assess the safety and tolerability of AMG 531 (romiplostim), a novel thrombopoiesis-stimulating peptibody, and its effect on platelet counts in adults with immune thrombocytopenic purpura. |
| NCT00147225 ↗ | AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin | Completed | Amgen | Phase 1/Phase 2 | 2005-08-01 | The goal of this clinical research study is to find the highest safe dose of AMG 531 that will decrease the risk and severity of thrombocytopenia (low platelet counts) in patients who have received chemotherapy. Researchers will also look at the safety and effectiveness of AMG 531 (Romiplostim). Primary Objectives: 1. To determine the clinical safety and tolerability of AMG 531 administered following chemotherapy in patients with advanced malignancy 2. To determine an optimal biologic dose (OBD) of AMG 531 administered in patients receiving chemotherapy known to cause severe thrombocytopenia 3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and platelet recovery following chemotherapy Secondary Objective: 1. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route post-chemotherapy |
| NCT00147225 ↗ | AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin | Completed | M.D. Anderson Cancer Center | Phase 1/Phase 2 | 2005-08-01 | The goal of this clinical research study is to find the highest safe dose of AMG 531 that will decrease the risk and severity of thrombocytopenia (low platelet counts) in patients who have received chemotherapy. Researchers will also look at the safety and effectiveness of AMG 531 (Romiplostim). Primary Objectives: 1. To determine the clinical safety and tolerability of AMG 531 administered following chemotherapy in patients with advanced malignancy 2. To determine an optimal biologic dose (OBD) of AMG 531 administered in patients receiving chemotherapy known to cause severe thrombocytopenia 3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and platelet recovery following chemotherapy Secondary Objective: 1. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route post-chemotherapy |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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