Romiplostim

Generic Name: Romiplostim

Brand Names: Nplate

Drug Type: Biotech

CAS Number: 267639-76-9

Unique Ingredient Identifier: GN5XU2DXKV

Background: Romiplostim is a thrombopoiesis stimulating dimer Fc-peptide fusion protein (peptibody) to increase platelet production through activation of the thrombopoietin receptor. The peptibody molecule has two identical single-chain subunits, each one is made up of 269 amino acid residues. Each subunit consists of an IgG1 Fc carrier domain that is covalently attached to a polypeptide sequence that contains two binding domains to interact with thrombopoietin receptor c-Mpl. Each domain consists of 14 amino acids. Interestingly, romiplostim's amino acid sequence is not similar to that of endogenous thrombopoietin. Romiplostim is produced by recombinant DNA technology in Escherichia coli. FDA approved on August 22, 2008.

Indication: Treatment of chronic immune thrombocytopenic purpura.

Associated Conditions: Chronic immune thrombocytopenia, Refractory immune thrombocytopenia

Clinical Trials

Safety of Romiplostim (Nplate®) Following UCBT

Phase 1

Completed

Conditions: Hematologic Malignancies

Interventions: Drug: Romiplostim

First Posted Date: 2014-01-27

Last Posted Date: 2021-06-08

Lead Sponsor: Masonic Cancer Center, University of Minnesota

Target Recruit Count: 21

Registration Number: NCT02046291

Locations: 🇺🇸
University of Minnesota Masonic Cancer Center, Minneapolis, Minnesota, United States

Using ROMIPLOSTINE for Persistent Thrombocytopenia With Transfusion-dependent Patients Who Received Allogeneic Hematopoietic Stem Cell

Phase 1

Completed

Conditions: Persistent Thrombocytopenia Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Interventions: Drug: Romiplostim

First Posted Date: 2013-11-08

Last Posted Date: 2019-02-15

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 24

Registration Number: NCT01980030

Locations: 🇫🇷
Saint Louis hospital, Paris, Ile De France, France

Secondary Prophylaxis in Non-Hodgkin Lymphoma (NHL) and Chemotherapy-induced Thrombocytopenia

Phase 2

Completed

Conditions: Non-Hodgkin Lymphoma

Interventions: Drug: Romiplostim

First Posted Date: 2012-01-25

Last Posted Date: 2022-08-12

Lead Sponsor: Andres J. M. Ferreri

Target Recruit Count: 3

Registration Number: NCT01516619

Locations: 🇮🇹
Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor, Milano, Italy

Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients

Phase 3

Completed

Conditions: Idiopathic Thrombocytopenic Purpura
Thrombocytopenia
Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Thrombocytopenic Purpura
Immune Thrombocytopenia

Interventions: Drug: Placebo
Drug: Romiplostim

First Posted Date: 2011-09-30

Last Posted Date: 2017-02-09

Lead Sponsor: Amgen

Target Recruit Count: 62

Registration Number: NCT01444417

Locations: 🇨🇦
Research Site, Quebec City, Quebec, Canada

Indirect Comparison Between Eltrombopag & Romiplostim

Completed

Conditions: Thrombocytopaenia

Interventions: Drug: Romiplostim
Drug: Eltrombopag
Drug: Placebo

First Posted Date: 2010-11-07

Last Posted Date: 2017-06-07

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 1

Registration Number: NCT01236014

Eltrombopag and the Bcl-extra-large (xL) Pathway in Idiopathic Thrombocytopenic Purpura (ITP)

Phase 2

Completed

Conditions: Immune Thrombocytopenia

Interventions: Drug: Eltrombopag
Drug: Romiplostim
Other: healthy controls

First Posted Date: 2009-05-14

Last Posted Date: 2019-03-18

Lead Sponsor: Weill Medical College of Cornell University

Target Recruit Count: 20

Registration Number: NCT00902018

Locations: 🇺🇸
Weill Cornell Medical College, New York, New York, United States

P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura

Phase 3

Completed

Conditions: Idiopathic Thrombocytopenic Purpura

Interventions: Drug: Placebo
Drug: AMG 531

First Posted Date: 2008-01-29

Last Posted Date: 2022-11-08

Lead Sponsor: Amgen

Target Recruit Count: 34

Registration Number: NCT00603642

Safety and Efficacy Study of Romiplostim (AMG 531) to Treat ITP in Pediatric Subjects

Phase 1

Completed

Conditions: Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Idiopathic Thrombocytopenic Purpura
Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)