Romiplostim

Generic Name: Romiplostim

Brand Names: Nplate

Drug Type: Biotech

Chemical Formula: -

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 attache...

Indication: Treatment of chronic immune thrombocytopenic purpura.

Associated Conditions: Chronic immune thrombocytopenia, Refractory immune thrombocytopenia

Associated Therapies: -

Clinical Trials

Evaluating the Pharmacokinetics and Pharmacodynamics of Romiplostim in Patients With Immune Thrombocytopenia (ITP)

Phase 1

Completed

Conditions: Immune Thrombocytopenia (ITP)

Interventions: Drug: Romiplostim

First Posted Date: 2016-08-16

Last Posted Date: 2024-04-29

Lead Sponsor: Kyowa Kirin China Pharmaceutical Co., Ltd.

Target Recruit Count: 16

Registration Number: NCT02868060

Locations: 🇨🇳
Wuxi People's Hospital, Wuxi, China
🇨🇳
Peking Union hospital, Beijing, China
🇨🇳
West China hospital, Chengdu, China

and more 2 locations

Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP)

Phase 3

Completed

Conditions: Immune Thrombocytopenia

Interventions: Drug: Romiplostim
Drug: Placebo

First Posted Date: 2016-08-16

Last Posted Date: 2024-04-29

Lead Sponsor: Kyowa Kirin China Pharmaceutical Co., Ltd.

Target Recruit Count: 203

Registration Number: NCT02868099

Locations: 🇨🇳
Peking Union Medical College Hospital, Beijing, China

Immunomodulation With Romiplostim in Young Adults With ITP

Phase 4

Completed

Conditions: Immune Thrombocytopenia

Interventions: Drug: romiplostim

First Posted Date: 2016-05-03

Last Posted Date: 2020-05-07

Lead Sponsor: University Hospital, Basel, Switzerland

Target Recruit Count: 15

Registration Number: NCT02760251

Locations: 🇨🇭
Lucerne Cantonal Hospital, Lucerne, Lucern, Switzerland
🇨🇭
Aarau Cantonal Hospital, Aarau, Switzerland
🇨🇭
Liestal Cantonal Hospital, Liestal, Basel-Land, Switzerland

and more 2 locations

An Observational Study to Evaluate the Efficacy of Biweekly Romiplostim in Adult Patients With ITP

Phase 2

Conditions: Immune Thrombocytopenia

Interventions: Drug: Romiplostim

First Posted Date: 2015-01-14

Last Posted Date: 2015-01-14

Lead Sponsor: Samsung Medical Center

Target Recruit Count: 20

Registration Number: NCT02338414

Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP)

Phase 3

Completed

Conditions: Immune Thrombocytopenia

Interventions: Drug: Romiplostim

First Posted Date: 2014-10-30

Last Posted Date: 2022-06-23

Lead Sponsor: Amgen

Target Recruit Count: 203

Registration Number: NCT02279173

Locations: 🇬🇧
Research Site, Manchester, United Kingdom

Prevention of Thrombocytopenia in Glioblastoma Patients

Phase 2

Terminated

Conditions: Glioblastoma
Thrombocytopenia

Interventions: Drug: Romiplostim

First Posted Date: 2014-08-28

Last Posted Date: 2018-04-25

Lead Sponsor: University Hospital, Lille

Target Recruit Count: 20

Registration Number: NCT02227576

Locations: 🇫🇷
AP-HM,Hôpital La Timone, AP-HM, Marseille, Marseille, France
🇫🇷
Hôpital Neurologique Pierre Wertheimer, Lyon,, Lyon, France
🇫🇷
AH-HP, Hôpital Pitié-Salpêtrière, Service de Neurologie 2, Paris, France

and more 1 locations

Study of Romiplostim for Chemotherapy Induced Thrombocytopenia

Phase 2

Completed

Conditions: Isolated Chemotherapy-induced Thrombocytopenia

Interventions: Biological: romiplostim

First Posted Date: 2014-02-03

Last Posted Date: 2024-10-26

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 60

Registration Number: NCT02052882

Locations: 🇺🇸
Memorial Sloan Kettering at Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States

and more 3 locations

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

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