CLINICAL TRIALS PROFILE FOR NPLATE
✉ Email this page to a colleague
Biosimilar Clinical Trials for NPLATE
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 NPLATE
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. |
NCT01153919 ↗ | Romiplostim in Treating Hepatitis C-Infected Patients With Thrombocytopenia | Terminated | University of Southern California | Phase 2 | 2010-06-30 | RATIONALE: Romiplostim may cause the body to make platelets. PURPOSE: This randomized phase II trial is studying how well romiplostim works in treating hepatitis C-infected patients with thrombocytopenia. |
NCT01516619 ↗ | Secondary Prophylaxis in Non-Hodgkin Lymphoma (NHL) and Chemotherapy-induced Thrombocytopenia | Unknown status | Amgen | Phase 2 | 2011-11-01 | This is a monocentric, prospective phase II trial addressing safety and capability to prevent grade-4 Chemotherapy-induced Thrombocytopenia (CIT) of romiplostim in patients with NHL. |
NCT01516619 ↗ | Secondary Prophylaxis in Non-Hodgkin Lymphoma (NHL) and Chemotherapy-induced Thrombocytopenia | Unknown status | Andres J. M. Ferreri | Phase 2 | 2011-11-01 | This is a monocentric, prospective phase II trial addressing safety and capability to prevent grade-4 Chemotherapy-induced Thrombocytopenia (CIT) of romiplostim in patients with NHL. |
NCT02046291 ↗ | Safety of Romiplostim (Nplate®) Following UCBT | Completed | Masonic Cancer Center, University of Minnesota | Phase 1 | 2015-04-10 | This is a single institution, phase I dose escalation study of weekly romiplostim post umbilical cord blood transplantation in patients who fail to achieve platelet engraftment by day +30. Engraftment is defined as a platelet count ≥ 20 x 109/L on 3 consecutive measurements without transfusion for 7 days. Romiplostim is administered at the assigned dose as 6 weekly injections beginning by day +42 post transplant. Up to 4 dose levels (4, 6, 8, and 10 mcg/kg/dose) will be evaluated with the maximum tolerated dose (MTD) of romiplostim determined by using the Continual Reassessment Method (CRM). The goal of this CRM will be to identify 1 of the 4 dose levels which corresponds to the desired maximum toxicity rate of 20% or less. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for NPLATE
Condition Name
Clinical Trial Locations for NPLATE
Trials by Country
Clinical Trial Progress for NPLATE
Clinical Trial Phase
Clinical Trial Sponsors for NPLATE
Sponsor Name