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Last Updated: September 25, 2020

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CLINICAL TRIALS PROFILE FOR ROMIPLOSTIM

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All Clinical Trials for romiplostim

Trial ID Title Status Sponsor Phase Start Date Summary
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
NCT00299182 Study of AMG 531 to Evaluate the Safety & Efficacy in Patients With Non-Hodgkin's Lymphoma Completed Amgen Phase 1/Phase 2 2006-03-01 The goal of this clinical research study is to find the highest safe dose of AMG 531 that can be given to treat thrombocytopenia (low platelet counts) in patients who have received chemotherapy. Researchers will also look at the safety and effectiveness of AMG 531. Primary Objectives: 1. To determine the clinical safety and tolerability of AMG 531 administered following chemotherapy (R-HyperCVAD alternating with R-Ara-C/MTX) in patients with non-Hodgkin's lymphoma. 2. To determine an optimal biologic dose (OBD) of AMG 531 in patients receiving R-HyperCVAD and R-Ara-C/MTX. 3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and platelet recovery following chemotherapy(chemo). Secondary Objectives: 1. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route with chemotherapy.
NCT00299182 Study of AMG 531 to Evaluate the Safety & Efficacy in Patients With Non-Hodgkin's Lymphoma Completed M.D. Anderson Cancer Center Phase 1/Phase 2 2006-03-01 The goal of this clinical research study is to find the highest safe dose of AMG 531 that can be given to treat thrombocytopenia (low platelet counts) in patients who have received chemotherapy. Researchers will also look at the safety and effectiveness of AMG 531. Primary Objectives: 1. To determine the clinical safety and tolerability of AMG 531 administered following chemotherapy (R-HyperCVAD alternating with R-Ara-C/MTX) in patients with non-Hodgkin's lymphoma. 2. To determine an optimal biologic dose (OBD) of AMG 531 in patients receiving R-HyperCVAD and R-Ara-C/MTX. 3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and platelet recovery following chemotherapy(chemo). Secondary Objectives: 1. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route with chemotherapy.
NCT00303472 Determination of Safe Dose of Romiplostim (AMG 531) in Patients With Myelodysplastic Syndromes (MDS) Completed Amgen Phase 2 2006-02-01 The purpose of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with low or Intermediate-1 risk MDS. In addition, the study will evaluate the platelet response to romiplostim.
NCT00321711 Determination of Safe and Effective Dose of Romiplostim (AMG 531) in Subjects With Myelodysplastic Syndrome (MDS)Receiving Hypomethylating Agents Completed Amgen Phase 2 2006-10-01 The purpose of this study is to evaluate the effect of Romiplostim (AMG 531) on the incidence of clinically significant thrombocytopenic events (grade 3 or 4 and/or receipt of platelet transfusions) in subjects with low or intermediate risk Myelodysplastic Syndrome (MDS) receiving hypomethylating agents. It is hypothesized that Romiplostim administration, at the appropriate dose and schedule, will result in reduction in the incidence of clinically significant thrombocytopenic events in low or intermediate risk MDS subjects receiving hypomethylating agents.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for romiplostim

Condition Name

Condition Name for romiplostim
Intervention Trials
Thrombocytopenia 10
Immune Thrombocytopenia 7
Myelodysplastic Syndromes 5
MDS 4
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Condition MeSH

Condition MeSH for romiplostim
Intervention Trials
Thrombocytopenia 26
Purpura, Thrombocytopenic, Idiopathic 11
Syndrome 6
Preleukemia 6
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Clinical Trial Locations for romiplostim

Trials by Country

Trials by Country for romiplostim
Location Trials
United States 73
Canada 8
Australia 6
France 4
Switzerland 4
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Trials by US State

Trials by US State for romiplostim
Location Trials
Texas 6
California 5
New York 5
Tennessee 4
Pennsylvania 4
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Clinical Trial Progress for romiplostim

Clinical Trial Phase

Clinical Trial Phase for romiplostim
Clinical Trial Phase Trials
Phase 4 2
Phase 3 5
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for romiplostim
Clinical Trial Phase Trials
Completed 11
Recruiting 10
Not yet recruiting 6
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Clinical Trial Sponsors for romiplostim

Sponsor Name

Sponsor Name for romiplostim
Sponsor Trials
Amgen 15
Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH 2
Kyowa Hakko Kirin China Pharmaceutical Co.,LTD. 2
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Sponsor Type

Sponsor Type for romiplostim
Sponsor Trials
Other 21
Industry 21
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