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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

Patients With Relapsed Ovarian Cancer (2nd and 3rd Line) Treated With Chemotherapy According to AGO Guidelines

Phase 2
Terminated
Conditions
Ovarian Cancer
Interventions
Drug: Standard chemotherapy
Drug: Placebos
First Posted Date
2018-08-09
Last Posted Date
2021-02-08
Lead Sponsor
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Target Recruit Count
21
Registration Number
NCT03622931
Locations
🇩🇪

Praxisklinik für Krebsheilkunde für Frauen Drs. Kittel /Klare / Wetzel, Berlin, Germany

🇩🇪

Charité Campus Virchow-Klinikum Universitätsmedizin Berlin, Berlin, Germany

🇩🇪

Ev. Waldkrankenhaus Spandau, Berlin, Germany

and more 10 locations

Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer

Phase 3
Completed
Conditions
Chemotherapy-induced Thrombocytopenia
Interventions
First Posted Date
2017-12-05
Last Posted Date
2025-01-20
Lead Sponsor
Amgen
Target Recruit Count
165
Registration Number
NCT03362177
Locations
🇵🇹

Centro Hospitalar Universitario de Sao Joao, EPE - Hospital Sao Joao, Porto, Portugal

🇷🇺

Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of Tatarstan, Kazan, Russian Federation

🇷🇺

Clinical hospital 2, Group of companies medsi, Moscow, Russian Federation

and more 113 locations

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

Phase 1
Completed
Conditions
Immune Thrombocytopenia (ITP)
Interventions
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: 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
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
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
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
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

A Phase 2 Study to Evaluate the Efficacy and Safety of AMG531 in Aplastic Anemia

Phase 2
Completed
Conditions
Aplastic Anemia
Interventions
First Posted Date
2014-03-21
Last Posted Date
2024-04-30
Lead Sponsor
Kyowa Kirin Korea Co., Ltd.
Target Recruit Count
35
Registration Number
NCT02094417
Locations
🇰🇷

Korea, Republic of, Seoul, Korea, Republic of

Study of Romiplostim for Chemotherapy Induced Thrombocytopenia

Phase 2
Completed
Conditions
Isolated Chemotherapy-induced Thrombocytopenia
Interventions
First Posted Date
2014-02-03
Last Posted Date
2024-12-27
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
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