Romiplostim N01

DRUG19 trials

Sponsors

Shandong University, Anhui Provincial Hospital, The First Affiliated Hospital with Nanjing Medical University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Institute of Hematology & Blood Diseases Hospital, China

Conditions

Acute Myeloid LeukemiaAdolescentAplastic AnemiaBreast CancerCTIT-Chemotherapy Induced ThrombocytopeniaCTIT: Cancer Therapy Induced ThrombocytopeniaCancer Treatment-induced Thrombocytopenia (CTIT)Cervical Cancer

Phase 1

Romiplostim N01 for Platelet Recovery After Haploidentical HSCT

RecruitingNCT07321626

First Affiliated Hospital of Zhejiang UniversityAcute Myeloid Leukemia, Delayed Platelet Engraftment, HSCT +1

Start: 2025-06-01End: 2027-12-01Target: 130Updated: 2026-01-28

Phase 2

Romiplostim N01 for Platelet Recovery in Adult Hematologic Malignancies Patients Undergoing UCBT

RecruitingNCT06693791

Anhui Provincial HospitalPlatelet Recovery After Umbilical Cord Blood Transplantation

Start: 2024-12-01End: 2026-12-01Target: 34Updated: 2024-11-18

Efficacy and Safety Study of Romiplostim N01 for Cancer Treatment-induced Thrombocytopenia (CTIT) in the Treatment of Leukemia

Not yet recruitingNCT06898983

Anhui Provincial HospitalCancer Treatment-induced Thrombocytopenia (CTIT)

Start: 2025-03-31End: 2027-02-28Target: 97Updated: 2025-03-28

Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia in Pediatric Cancer Patients

RecruitingNCT07043894

Cancer Institute and Hospital, Chinese Academy of Medical SciencesAdolescent, Chemotherapy Induced Thrombocytopenia, Children +2

Start: 2025-12-25End: 2026-09-01Target: 50Updated: 2026-05-07

Romiplostim N01 for Chemotherapy-induced Thrombocytopenia

RecruitingNCT07063225

Institute of Hematology & Blood Diseases Hospital, ChinaChemotherapy-induced Thrombocytopenia, Romiplostim N01

Start: 2025-08-31End: 2026-08-31Target: 50Updated: 2025-07-14

Romiplostim N01 for the Treatment of Thrombocytopenia Associated With Radiotherapy-Combined Treatment Regimens in Patients With Solid Tumors

Not yet recruitingNCT07128576

Zhujiang HospitalSolid Tumors

Start: 2025-09-15End: 2028-12-31Target: 60Updated: 2025-09-04

Phase II Study of Orelabrutinib in Combination With Romiplostim N01 in Patients With Primary Immune Thrombocytopenia (ITP) Who Have Received At Least One Prior Line of Therapy

Not yet recruitingNCT07400250

Peking Union Medical College HospitalPrimary Immune Thrombocytopenia (ITP)

Start: 2026-04-01End: 2028-10-01Target: 28Updated: 2026-02-10

CsA+EPAG/HPAG+Romiplostim N01 in the Treatment of Newly-diagnosed SAA/TD-NSAA

Not yet recruitingNCT07523009

Peking Union Medical College HospitalSevere Aplastic Anemia (SAA), Transfusion-dependent Non-severe Aplastic Anemia

Start: 2026-04-01End: 2029-12-01Target: 43Updated: 2026-04-13

Romiplostim N01 in the Treatment of Refractory Chemoradiotherapy-induced AA

Not yet recruitingNCT07532408

Peking Union Medical College HospitalAplastic Anemia

Start: 2026-04-01End: 2029-12-01Target: 43Updated: 2026-04-15

CsA+EPAG/HPAG+Romiplostim N01 in Newly-diagnosed SAA/TD-NSAA

Not yet recruitingNCT07558434

Peking Union Medical College HospitalSevere Aplastic Anemia (SAA), Transfusion-dependent Non-severe Aplastic Anemia

Start: 2026-04-01End: 2029-12-01Target: 43Updated: 2026-04-30

Romiplostim N01 in Chemoradiotherapy-induced Aplastic Anemia

Not yet recruitingNCT07572084

Peking Union Medical College HospitalAplastic Anemia

Start: 2026-04-01End: 2029-12-01Target: 43Updated: 2026-05-07

Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gastrointestinal Solid Tumors

RecruitingNCT07586813

Peking University People's HospitalChemotherapy-Induced Thrombocytopenia, Colorectal Cancer, Gastrointestinal Neoplasms +2

Start: 2025-12-22End: 2027-12-31Target: 220Updated: 2026-05-14

Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gynecologic, Breast, or Lung Solid Tumors

RecruitingNCT07586826

Peking University People's HospitalBreast Cancer, Cervical Cancer, Chemotherapy-Induced Thrombocytopenia +7

Start: 2025-12-22End: 2027-12-31Target: 220Updated: 2026-05-14

Phase 3

A Multicenter Randomized Controlled Study on the Treatment of Refractory CTIT With Romiplostim N01 Compared to Recombinant Human Thrombopoietin

Not yet recruitingNCT06440824

Shandong UniversityCTIT-Chemotherapy Induced Thrombocytopenia

Start: 2024-06-01End: 2025-11-30Target: 60Updated: 2024-06-04

A Study on the Treatment of CTIT of the Efficacy and Safety With Romiplostim N01 Compared to Recombinant Human Interleukin-11

RecruitingNCT06759636

The First Affiliated Hospital with Nanjing Medical UniversityCTIT: Cancer Therapy Induced Thrombocytopenia

Start: 2025-02-24End: 2026-07-21Target: 88Updated: 2026-04-14

A Study of Romiplostim N01 Plus IST vs. Placebo Plus IST for Treatment-Naive Severe Aplastic Anemia

Not yet recruitingNCT07345000

Qilu Pharmaceutical Co., Ltd.Treatment-naïve Severe Aplastic Anemia

Start: 2026-01-31End: 2030-08-31Target: 210Updated: 2026-01-15

Unknown Phase

Romiplostim N01 in the Treatment of Thrombocytopenia Caused by Cytotoxic Drugs in Breast Cancer Patients

Not yet recruitingNCT07162519

Tianjin Medical University Cancer Institute and HospitalBreast Cancer, Cytotoxic Drugs, Romiplostim N01

Start: 2025-09-20End: 2026-11-30Target: 68Updated: 2025-09-09

A Multicenter, Open-label, Randomized Controlled Trial Evaluating the Efficacy and Safety of Romiplostim N01 in the Treatment of Thrombocytopenia Associated With Concurrent/Sequential Chemoradiotherapy and Chemotherapy Combined With/Without Immunotherapy in Solid Tumors

Not yet recruitingNCT07185893

Jun wangCTIT-Chemotherapy Induced Thrombocytopenia, Solid Tumor Malignancies, Cancer, Thrombocytopenia

Start: 2025-09-30End: 2028-12-31Target: 106Updated: 2025-09-22

Efficacy and Safety of Romiplostim N01 Combined With Rituximab in Patients With Oral TPO-RA-Refractory Primary Immune Thrombocytopenia

RecruitingNCT07206823

The First Affiliated Hospital of Soochow UniversityPrimacy Immune Thrombocytopenia

Start: 2025-09-01End: 2027-07-31Target: 30Updated: 2025-12-04