NCT04095936 is a Phase 2, PHASE3 clinical trial of Romiplostim in Aplastic Anemia, sponsored by Kyowa Kirin Co., Ltd..

Who is sponsoring NCT04095936?

NCT04095936 is sponsored by Kyowa Kirin Co., Ltd..

What drugs are being tested in NCT04095936?

Interventions in NCT04095936: Romiplostim.

What condition does NCT04095936 study?

NCT04095936 studies Aplastic Anemia.

Is NCT04095936 still recruiting?

NCT04095936 is currently completed. Last updated 26 May 2022.

Last reviewed 2022-05-26 · How we verify

NCT04095936

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of AMG531 (Romiplostim) in Patients With Aplastic Anemia

Completed Phase 2, PHASE3 Last updated 26 May 2022

What this trial tests

Phase 2, PHASE3 trial testing Romiplostim in Aplastic Anemia in 24 participants. Completed in 29 October 2021.

Timeline

3 December 2019

Primary endpoint
7 October 2021

29 October 2021

Quick facts

Lead sponsor	Kyowa Kirin Co., Ltd.
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	3 December 2019
Primary completion	7 October 2021
Estimated completion	29 October 2021
Sites	1 location across Japan

Drugs / interventions tested

Romiplostim (ROMIPLOSTIM) — full drug profile →

Conditions studied

Aplastic Anemia — all drugs for Aplastic Anemia →

Sponsor

Kyowa Kirin Co., Ltd. — full company profile →

Who can join

20 and older, any sex, with Aplastic Anemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate the hematological responses based on the response assessment criteria defined in this study (the 531-004 response assessment criteria) when AMG531 is subcutaneously (SC)-administered with ciclosporin A (CsA) therapy for 6 months in patients with aplastic anemia (AA) who were previously untreated with immunosuppressive therapy.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

A Review of Romiplostim Mechanism of Action and Clinical Applicability.
Bussel JB, Soff G, Balduzzi A, Cooper N, et al · · 2021 · cited 60× · PMID 34079225 · DOI 10.2147/dddt.s299591
Romiplostim with ciclosporin A in patients with aplastic anaemia naïve to immunosuppressive therapy: A phase 2/3 study.
Lee JW, Jang JH, Chiba S, Yoon SS, et al · · 2025 · cited 3× · PMID 40639944 · DOI 10.1111/bjh.20206
P777: EFFICACY AND SAFETY OF ROMIPLOSTIM COMBINED WITH CYCLOSPORINE A AS A FIRST-LINE TREATMENT IN PATIENTS WITH APLASTIC ANEMIA: A PHASE 2/3 CLINICAL TRIAL.
Chiba S, Wook Lee J, Ho Jang J, Yoon S, et al · · 2023

Verify or expand the search:

Other trials of Romiplostim

Trials testing the same drug.

NCT07001254 — UI-Romi-02; Romiplostim Added to Standard of Care for Treatment Naive and Relapsed or Refractory Severe Aplastic Anemia · Phase 2 · not yet recruiting
NCT07400341 — Romiplostim Versus rhTPO for Platelet Engraftment After Transplant in MDS and AA · Phase 2 · recruiting
NCT06345495 — High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly · Phase 2 · recruiting
NCT07003256 — Observational Study: Romiplostim for Platelet Recovery in Haploidentical HSCT · enrolling by invitation
NCT06535685 — A Study of Romiplostim for the Treatment of Refractory Transfusion-dependent NSAA · Phase 4 · not yet recruiting

Other recruiting trials for Aplastic Anemia

Currently open trials in the same condition.

NCT07101770 — A Prediction Model in Pregnant Women With Aplastic Anemia · recruiting
NCT06752694 — Ruxolitinib Based GVHD Prophylaxis Regimen Before, During, and After Hematopoietic Cell Transplantation in Older Adult P · Phase 2 · recruiting
NCT06936930 — Reproductive and Mental Health of Patients With Aplastic Anemia · recruiting
NCT06689800 — Let's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy · NA · recruiting
NCT06613880 — Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia · Phase 2 · recruiting

Other Kyowa Kirin Co., Ltd. trials

Trials by the same sponsor.

NCT06926491 — Evaluate the Efficacy and Safety of KK8398 in Patients With Achondroplasia（AOBA Study） · Phase 3 · recruiting
NCT06812104 — Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia · Phase 1 · recruiting
NCT06525636 — A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia · Phase 1, PHASE2 · recruiting
NCT06116890 — Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration · Phase 2 · active not recruiting
NCT06116916 — Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema · Phase 2 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04095936 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kyowa Kirin Co., Ltd.
Last refreshed: 26 May 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04095936.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing