CLINICAL TRIALS PROFILE FOR ROMIPLOSTIM

Biosimilar Clinical Trials for romiplostim

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05621330 ↗	Efficacy and Safety of QL0911 in Adult Patients With Chronic Primary Immune Thrombocytopenia: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Trial	Completed	Qilu Pharmaceutical Co., Ltd.	Phase 3	2019-10-18	QL0911, a recombinant human thrombopoietin mimetic peptide-Fc fusion protein for injection, is a romiplostim (Nplate®) biosimilar for the treatment of primary immune thrombocytopenia (ITP). This phase III study aimed to assess the efficacy and safety of QL0911 in adults' patients with primary chronic ITP during a 24-week treatment period.

All Clinical Trials for romiplostim

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00111475 ↗	Evaluating the Safety and Efficacy of Romiplostim (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)	Completed	Amgen	Phase 2	2002-07-01	The primary objective of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with ITP.
NCT00117143 ↗	Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)	Completed	Amgen	Phase 1/Phase 2	2002-12-02	The purpose of this study is to assess the safety and tolerability of AMG 531 (romiplostim), a novel thrombopoiesis-stimulating peptibody, and its effect on platelet counts in adults with immune thrombocytopenic purpura.
NCT00147225 ↗	AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin	Completed	Amgen	Phase 1/Phase 2	2005-08-01	The goal of this clinical research study is to find the highest safe dose of AMG 531 that will decrease the risk and severity of thrombocytopenia (low platelet counts) in patients who have received chemotherapy. Researchers will also look at the safety and effectiveness of AMG 531 (Romiplostim). Primary Objectives: 1. To determine the clinical safety and tolerability of AMG 531 administered following chemotherapy in patients with advanced malignancy 2. To determine an optimal biologic dose (OBD) of AMG 531 administered in patients receiving chemotherapy known to cause severe thrombocytopenia 3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and platelet recovery following chemotherapy Secondary Objective: 1. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route post-chemotherapy

Clinical Trial Conditions for romiplostim

Condition Name

Condition Name for romiplostim
Intervention	Trials
Immune Thrombocytopenia	12
Thrombocytopenia	11
MDS	5

Condition MeSH

Condition MeSH for romiplostim
Intervention	Trials
Thrombocytopenia	36
Purpura, Thrombocytopenic, Idiopathic	20
Purpura, Thrombocytopenic	8

Clinical Trial Locations for romiplostim

Trials by Country

Trials by Country for romiplostim
Location	Trials
United States	101
Canada	8
Spain	8
China	6
Brazil	6

Trials by US State

Trials by US State for romiplostim
Location	Trials
New York	9
New Jersey	7
Texas	7
Illinois	6
California	6

Clinical Trial Progress for romiplostim

Clinical Trial Phase

Clinical Trial Phase for romiplostim
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	7
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for romiplostim
Clinical Trial Phase	Trials
Completed	23
Recruiting	12
Not yet recruiting	6

Clinical Trial Sponsors for romiplostim

Sponsor Name

Sponsor Name for romiplostim
Sponsor	Trials
Amgen	20
Memorial Sloan Kettering Cancer Center	3
Kyowa Hakko Kirin China Pharmaceutical Co.,LTD.	2

Sponsor Type

Sponsor Type for romiplostim
Sponsor	Trials
Industry	34
Other	34