17 completed, 3 active not recruiting, 1 recruiting, 1 unknown. 23 Phase 3, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 23 | Completed 17, Active not recruiting 3, Recruiting 1, Unknown 1, Withdrawn 1 |
| Phase 2 | 4 | Completed 4 |
Follow romiplostim: new trials by email Literature Review of romiplostim trials Research Report on romiplostim
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Previously Untreated Primary Immune Thrombocytopenia (ITP) Romiplostim, Predniso(lo)ne - Primary Immune Thrombocytopenia | Phase 3 | Recruiting | Amgen | 126 | 2026-08-21 | 2026-09-17 |
| Romiplostim in Chemotherapy-Induced Thrombocytopenia Romiplostim - Chemotherapy-induced Thrombocytopenia, Solid Malignancy | Phase 3 | Unknown | Ain Shams University | 30 | 2023-12-17 | 2024-01-11 |
| Study of Efficacy, Safety and Immunogenicity of GP40141 (GEROPHARM, Russia) in Patients With Immune Thrombocytopenia GP404141, Nplate - Drug Effect, Safety Issues | Phase 3 | Active not recruiting | Geropharm | 160 | 2023-04-04 | 2024-07-11 |
| Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia romiplostim plus dexamethasone, Dexamethasone - Primary Immune Thrombocytopenia | Phase 3 | Active not recruiting | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla | 129 | 2022-12-02 | 2025-06-17 |
| Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients GNR-069 - Idiopathic Thrombocytopenic Purpura | Phase 3 | Completed | AO GENERIUM | 160 | 2022-03-28 | 2024-06-21 |
| Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP GNR-069, Nplate - Idiopathic Thrombocytopenic Purpura | Phase 3 | Completed | AO GENERIUM | 160 | 2021-09-09 | 2024-03-06 |
| Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer Romiplostim, Placebo - Chemotherapy-induced Thrombocytopenia | Phase 3 | Active not recruiting | Amgen | 145 | 2020-02-26 | 2026-10-19 |
| Study of AMG531 (Romiplostim) in Patients With Aplastic Anemia Romiplostim - Aplastic Anemia | Phase 2 / Phase 3 | Completed | Kyowa Kirin Co., Ltd. | 24 | 2019-12-03 | 2022-05-26 |
| Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer Romiplostim, Placebo - Chemotherapy-induced Thrombocytopenia | Phase 3 | Completed | Amgen | 165 | 2019-09-30 | 2026-10-23 |
| Study of AMG531(Romiplostim) in Patients With Aplastic Anemia Romiplostim - Aplastic Anemia | Phase 2 / Phase 3 | Completed | Kyowa Kirin Co., Ltd. | 17 | 2019-04-25 | 2022-05-26 |
| Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Lymphoma. Romiplostim, Placebo - Chemotherapy-induced Thrombocytopenia | Phase 3 | Withdrawn | Amgen | 2018-01-27 | 2018-01-19 | |
| Study of Romiplostim(AMG531) in Subjects With Aplastic Anemia Romiplostim - Aplastic Anemia | Phase 2 / Phase 3 | Completed | Kyowa Kirin Co., Ltd. | 46 | 2016-05-01 | 2024-07-16 |
| Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP) Romiplostim, Placebo - Immune Thrombocytopenia | Phase 3 | Completed | Kyowa Kirin China Pharmaceutical Co., Ltd. | 203 | 2015-09-01 | 2024-04-29 |
| Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP) Romiplostim - Immune Thrombocytopenia | Phase 3 | Completed | Amgen | 203 | 2014-12-10 | 2022-06-23 |
| Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients Romiplostim, Placebo - Idiopathic Thrombocytopenic Purpura, Thrombocytopenia | Phase 3 | Completed | Amgen | 62 | 2012-01-01 | 2017-02-09 |
| A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Patients With Immune (Idiopathic) Thrombocytopenia Purpura Romiplostim - Thrombocytopenia in Pediatric Subjects With Immune Idiopathic Thrombocytopenic Purpura ITP | Phase 3 | Completed | Amgen | 66 | 2009-12-30 | 2020-01-18 |
| P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura Placebo, AMG 531 - Idiopathic Thrombocytopenic Purpura | Phase 3 | Completed | Amgen | 34 | 2007-10-01 | 2022-11-08 |
| Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura Medical Standard of Care for ITP, Romiplostim - Idiopathic Thrombocytopenic Purpura, Thrombocytopenia | Phase 3 | Completed | Amgen | 234 | 2006-12-01 | 2022-11-08 |
| Open Label Extension Study of AMG 531 in Japanese Subjects With ITP AMG 531 - Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Phase 2 / Phase 3 | Completed | Kyowa Kirin Co., Ltd. | 44 | 2006-11-01 | 2020-01-21 |
| AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy AMG 531, Placebo - Thrombocytopenia, Idiopathic Thrombocytopenic Purpura | Phase 3 | Completed | Amgen | 62 | 2005-04-07 | 2022-11-08 |
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Purpura, Thrombocytopenic, Idiopathic (14) · Thrombocytopenia (10) · Purpura, Thrombocytopenic (7) · Anemia, Aplastic (3) · Ecchymosis (2) · Hematologic Diseases (2) · Hemorrhage (2) · Hemostatic Disorders (2) · Jacobs syndrome (2) · Purpura (2) · Breast Neoplasms (1) · Carcinoma, Non-Small-Cell Lung (1) · Colorectal Neoplasms (1) · Gastrointestinal Neoplasms (1) · Ovarian Neoplasms (1)
Amgen (13) · Kyowa Kirin Co., Ltd. (4) · AO GENERIUM (2) · Ain Shams University (1) · Fundación Pública Andaluza para la gestión de la Investigación en Sevilla (1) · Geropharm (1) · Kyowa Kirin China Pharmaceutical Co., Ltd. (1)
United States (6) · Russia (5) · Spain (5) · Canada (4) · Japan (4) · Australia (3) · Brazil (3) · Mexico (3) · Poland (3) · Turkey (Türkiye) (3) · Argentina (2) · France (2) · Greece (2) · Hungary (2) · Italy (2)
Oksana A. Markova, MD, MSc (2) · Bulat Bakirov, MD (1) · Charlotte Bradbury (1) · Dmitry Kirtbaya (1) · Elena Borisenkova (1) · Galina Salogub (1) · Igor Davydkin (1) · Olga Vinogradova (1)
PMID 19671919, PMID 18242413, PMID 22494019, PMID 23753021, PMID 27103127, PMID 37601010, PMID 40593138, PMID 40708707
2017 (2), 2009 (1)