Long Term Follow-up Observational Study After Clinical Trials of AMG531 (Romiplostim) in Patients With Untreated Aplastic Anemia
NCT04870346 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 36
Last updated 2025-09-11
Summary
To evaluate the long-term efficacy and safety after the end of romiplostim treatment by observation \[up to 5 years\] of patients who were registered for Study 531-003/531-004 in immunosuppressive therapy-naïve patients with aplastic anemia.
Conditions
- Aplastic Anemia
Sponsors & Collaborators
-
Kyowa Kirin Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Hirohito Yamazaki · Kanazawa University Hospital, Blood Transfusion Department
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-10
- Primary Completion
- 2024-08-31
- Completion
- 2027-06-30
Countries
- Japan
Study Locations
More Related Trials
-
Safety Study of AMG 531 in Japanese Subjects With ITP
NCT00305435 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluating the Safety of Long Term Dosing of Romiplostim (Formerly AMG 531) in Thrombocytopenic Subjects With Myelodysplastic Syndromes (MDS)
NCT00472290 ·Status: COMPLETED ·Phase: NA
-
Eltrombopag in Combination With Rabbit Anti-thymocyte Globulin/Cyclosporine A in Naive Aplastic Anemia (AA) Subjects
NCT02404025 ·Status: COMPLETED ·Phase: PHASE2
-
Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia
NCT06613880 ·Status: RECRUITING ·Phase: PHASE2
-
Avatrombopag Combined With IST as First-line Treatment for SAA
NCT05720234 ·Status: UNKNOWN ·Phase: PHASE2
-
Efficacy and Safety of Hetrombopag in Non-severe Aplastic Anemia
NCT05018936 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
UI-Romi-02; Romiplostim Added to Standard of Care for Treatment Naive and Relapsed or Refractory Severe Aplastic Anemia
NCT07001254 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Study to Assess the Safety and Efficacy of Eltrombopag in Japanese Subjects With Refractory, Moderate or More Severe Aplastic Anemia
NCT02148133 ·Status: COMPLETED ·Phase: PHASE2
-
An Observational, Multicenter Study to Evaluate the Safety and Effectiveness of Hetrombopag in Patients With ITP or AA
NCT05333861 ·Status: NOT_YET_RECRUITING
-
Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia
NCT05325593 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Romiplostim N01 for Platelet Recovery in Adult Hematologic Malignancies Patients Undergoing UCBT
NCT06693791 ·Status: RECRUITING ·Phase: PHASE2
-
A Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Severe Aplastic Anemia (SAA) Patient
NCT03557099 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Open Label Extension Study of AMG 531 in Japanese Subjects With ITP
NCT00440037 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Using ROMIPLOSTINE for Persistent Thrombocytopenia With Transfusion-dependent Patients Who Received Allogeneic Hematopoietic Stem Cell
NCT01980030 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
An Observational Study to Evaluate the Efficacy of Biweekly Romiplostim in Adult Patients With ITP
NCT02338414 ·Status: UNKNOWN ·Phase: PHASE2
-
Hetrombopag or Placebo in Treatment-Naive Severe Aplastic Anemia
NCT03825744 ·Status: COMPLETED ·Phase: PHASE3
-
Real-world Outcomes of Aplastic Anemia Patients Treated With Eltrombopag: A Medical Claims Database Study
NCT06991894 ·Status: COMPLETED
-
Efficacy and Safety of Romiplostim N01 Combined With Rituximab in Patients With Oral TPO-RA-Refractory Primary Immune Thrombocytopenia
NCT07206823 ·Status: RECRUITING ·Phase: NA
-
Combination of Eltrombopag With Immunosuppressive Therapy in East-Asian Patients With Severe Aplastic Anemia
NCT04328727 ·Status: COMPLETED ·Phase: PHASE2
-
A Trial of Hetrombopag in Healthy and Hepatic Impairment Subjects
NCT05088642 ·Status: COMPLETED ·Phase: PHASE1
-
Study on Bone Marrow Morphology in Adults Receiving Romiplostim for Treatment of Thrombocytopenia Associated With Immune Thrombocytopenia Purpura (ITP)
NCT00907478 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy of Romiplostim in Immune Thrombocytopenia (ITP) in the " Real-life " : Result of the French Experience in 72 Adults
NCT01013181 ·Status: COMPLETED
-
Efficacy and Safety of Eltrombopag + Tacrolimus in Chinese Refractory or Relapsed Aplastic Anemia Patients
NCT04403321 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluating the Safety and Efficacy of Romiplostim (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
NCT00111475 ·Status: COMPLETED ·Phase: PHASE2
-
Extension Study of Hetrombopag in Severe Aplastic Anemia
NCT04961710 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3