Nplate®

Generic Name: romiplostim
Study IDStudied Indication or DiseasePhaseStudy TitleSynopsis
20010218Immune (idiopathic) thrombocytopenic purpura1/2An Open-label, Unit Dose-finding Study Evaluating the Safety and Efficacy of Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
20030105Thrombocytopenia associated with ITP3A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy
20030212Thrombocytopenia associated with ITP3A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy
20030213Thrombocytopenia in subjects with ITP3

An Open-label Study Evaluating the Safety and Efficacy of Long-term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

20040209Immune (Idiopathic) Thrombocytopenic Purpura (ITP)3

An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

20050144Chemotherapy-induced thrombocytopenia1/2
An Open Label Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 for
Treatment of Severe Thrombocytopenia Due to Multi-Cycle Chemotherapy in Adult Subjects with Lymphoma
20050154Advanced Non-Small Cell Lung Cancer2

Phase 2, Randomized, Double Blind, Placebo-Controlled Dose and Schedule Finding Trial to Evaluate the Safety and Efficacy of AMG 531 for Treatment of Chemotherapy-Induced Thrombocytopen

20050159AMG 531 for Thrombocytopenia associated with MDS2

An Open Label, Sequential Cohort, Dose Escalation Study to Evaluate the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects with Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

20050232Thrombocytopenia associated with hypomethylating agent therapy in MDS2

A Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Romiplostim Treatment of Subjects with Low or Intermediate Risk Myelodysplastic Syndrome (MDS) Receiving Hypomethylating Agents

20060102Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)2

A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim Treatment of Subjects with Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) Receiving Lenalidomide

20060113Thrombocytopenia in adult subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)Open Label ExtensionAn Open Label Extension Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Japanese Subjects with Immune (Idiopathic)Thrombocytopenic Purpura
20060131Immune (Idiopathic) Thrombocytopenic Purpura3

A Randomized, Controlled, Open-label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura

20060195Immune (Idiopathic) Thrombocytopenic Purpura (ITP)1/2

A Randomized, Double-Blind, Placebo-controlled Phase 1/2 Study to Determine the Safety and Efficacy of Romiplostim in Thrombocytopenic Pediatric Subjects with Chronic Immune (Idiopathic) Thrombocytopenic Purpura

20060197Thrombocytopenia associated with MDSOLE

An Open Label Extension Study Evaluating the Safety of Long Term Dosing of Romiplostim in Thrombocytopenic Subjects with Myelodysplastic Syndromes (MDS)

20060198MDS-related thrombocytopenia2

A Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim Treatment of Thrombocytopenia in Subjects with Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

20060216Thrombocytopenia in adult subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)3

A Randomized, Double Blind, Placebo Controlled Phase 3 Study Evaluating the Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects with Immune (Idiopathic) Thrombocytopenic Purpura

20080009Thrombocytopenia associated with ITP4

A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in Bone Marrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment of Thrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)

20080046Platelets 10 to 30 x 109 /L in second or third trimesterPostmarketing

Nplate® Pregnancy Exposure Registry (NPER)

20080435Adult immune thrombocytopenia purpura (ITP)2A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim