A Multicenter, Single-Arm Study of Romiplostim N01 in Megakaryocytic Engraftment after Allogeneic Hematopoietic Stem Cell Transplantation for Bone Marrow Failure Diseases

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600116641

Enrollment

Unknown

Registered

2026-01-13

Start date

2026-01-19

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Marrow Failure Diseases

Interventions

Test group:Romiplostim N01

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Previously diagnosed with SAA, MDS or MF and received allogeneic hematopoietic stem cell transplantation treatment; 2. PLT = 18 years old, gender not restricted; 4. ECOG performance status score of 0, 1 or 2; 5. Patients with an estimated life expectancy of at least 6 months as determined by the investigator; 6.Patients who voluntarily provided written informed consent prior to trial screening.

Exclusion criteria

Exclusion criteria: 1. Subjects with a prior history of romiplostim (N01) treatment; 2.History of other progressive malignancies within the past 3 years; 3.Uncontrolled medical conditions including but not limited to cardiovascular or cerebrovascular diseases, coagulation disorders, connective tissue diseases, or severe infectious diseases; 4. Left ventricular ejection fraction 2 × upper limit of normal (ULN), or alkaline phosphatase (AKP) and bilirubin > 1.5 × ULN; 6. Serum creatinine > 1.5 × ULN; 7.Patients with psychiatric disorders or those known or suspected to be unable to fully comply with the study protocol; 8. History of stroke, deep vein thrombosis (DVT), pulmonary embolism, or arterial embolism within 6 months prior to enrollment; 9.History of severe, immediate, or hypersensitivity reactions to any excipient of the investigational drug; 10.Any other concurrent uncontrolled medical condition that, in the judgment of the investigator, may affect the subject’s participation in the study.

Design outcomes

Primary

Measure	Time frame
Platelet implantation rate;	—

Secondary

Measure	Time frame
Median time for PLT >= 50 × 10^9 /l and PLT >= 100 × 10^9/l;Bleeding events;Drug related adverse reactions;Post transplant complications;Overall survival;Disease status;	—

Countries

China

Contacts

Public ContactMiao Miao

The First Affiliated Hospital of Soochow University

cher222@163.com+86 512 6778 0337

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026