MedPath

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

Romiplostim in Combination With CsA vs. CsA in the Treatment of Newly Diagnosed NSAA

Phase 4
Not yet recruiting
Conditions
Non Severe Aplastic Anemia
Interventions
First Posted Date
2023-08-24
Last Posted Date
2023-08-24
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
44
Registration Number
NCT06009497
Locations
🇨🇳

Peking union medical college hospital, Beijing, China

Immune Thrombocytopenia Management in Adults

Phase 4
Recruiting
Conditions
Immune Thrombocytopenia Purpura
Interventions
First Posted Date
2023-05-16
Last Posted Date
2023-05-16
Lead Sponsor
Nahda University
Target Recruit Count
467
Registration Number
NCT05861297
Locations
🇪🇬

EL-Kasr elineiy, Cairo, Egypt

Evaluating the Efficacy and Safety of QL0911 in Chemotherapy- Induced Thrombocytopenia

Phase 2
Completed
Conditions
Chemotherapy-induced Thrombocytopenia
Interventions
First Posted Date
2023-05-09
Last Posted Date
2023-05-09
Lead Sponsor
Qilu Pharmaceutical Co., Ltd.
Target Recruit Count
50
Registration Number
NCT05851027
Locations
🇨🇳

Shanghai East Hospital, Shanghai, Shanghai, China

Double-blind, Randomized Comparative Cross-sectional Study of Pharmacodynamics and Pharmacokinetics of Drugs GP40141

Phase 1
Recruiting
Conditions
Pharmacokinetics
Bioequivalence
Pharmacodynamics
Interventions
First Posted Date
2022-12-15
Last Posted Date
2022-12-15
Lead Sponsor
Geropharm
Target Recruit Count
56
Registration Number
NCT05652595
Locations
🇷🇺

Yaroslavl Region "Clinical Hospital No. 3", ,, Mayakovskogo st., 61, Yaroslavl, Russian Federation

Efficacy and Safety of QL0911 in Adult Patients With Chronic Primary Immune Thrombocytopenia

Phase 3
Completed
Conditions
Primary Immune Thrombocytopenia
Interventions
Drug: Placebo comparator
First Posted Date
2022-11-18
Last Posted Date
2022-11-23
Lead Sponsor
Qilu Pharmaceutical Co., Ltd.
Target Recruit Count
216
Registration Number
NCT05621330
Locations
🇨🇳

Qilu Hospital of Shandong University, Shandong, China

Evaluating the Efficacy and Safety of QL0911 in the Prevention of Chemotherapy- Induced Thrombocytopenia

Phase 2
Completed
Conditions
Chemotherapy-induced Thrombocytopenia
Interventions
Drug: Placebo
First Posted Date
2022-09-26
Last Posted Date
2024-10-18
Lead Sponsor
Qilu Pharmaceutical Co., Ltd.
Target Recruit Count
63
Registration Number
NCT05554913
Locations
🇨🇳

Shanghai East Hospital, Shanghai, Shanghai, China

Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia

Phase 3
Recruiting
Conditions
Primary Immune Thrombocytopenia
Interventions
First Posted Date
2022-04-13
Last Posted Date
2024-03-18
Lead Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Target Recruit Count
126
Registration Number
NCT05325593
Locations
🇪🇸

Hospital del Mar, Barcelona, Spain

🇪🇸

Centre Sociosanitari Sant Jordi de la Vall D'Hebron, Barcelona, Spain

🇪🇸

Complejo Asistencial Universitario de Burgos, Burgos, Spain

and more 12 locations

Efficacy of Romiplostim in Treatment of SAA in Adults Previously Untreated With or Refractory to Immunosuppressive Therapy

Phase 2
Withdrawn
Conditions
Severe Aplastic Anemia (SAA)
Interventions
Drug: Antithymocyte Globulin
First Posted Date
2022-04-12
Last Posted Date
2023-09-29
Lead Sponsor
Amgen
Registration Number
NCT05323617

Phase II Trial of Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-meth Glioblastoma

Phase 2
Withdrawn
Conditions
First Progression of MGMT Promoter-methylated Glioblastoma
Interventions
First Posted Date
2021-06-22
Last Posted Date
2023-05-24
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Registration Number
NCT04933942
Locations
🇪🇸

Hospital Universitario Ramon y Cajal, Madrid, Spain

🇪🇸

Hospital Universitario 12 De Octubre, Madrid, Spain

🇨🇭

UniversitaetsSpital, Zürich, Switzerland

and more 2 locations

Using Romiplostim to Treat Low Platelet Counts During Chemotherapy in People With Lymphoma

Phase 2
Active, not recruiting
Conditions
Lymphoma Patients
Thrombocytopenia
Interventions
First Posted Date
2020-12-17
Last Posted Date
2024-08-23
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
11
Registration Number
NCT04673266
Locations
🇺🇸

Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Nassau (All Protocol Activities), Uniondale, New York, United States

🇺🇸

Memorial Sloan Kettering Basking Ridge (All Protocol Activites), Basking Ridge, New Jersey, United States

and more 5 locations
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