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Romiplostim N01 for Enhancement of Platelet Engraftment in Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation: A Prospective, Single-arm, Multicenter Study

Romiplostim N01 for Enhancement of Platelet Engraftment in Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation: A Prospective, Single-arm, Multicenter Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096999
Enrollment
Unknown
Registered
2025-02-11
Start date
2025-02-28
Completion date
Unknown
Last updated
2025-02-17

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

Conditions

Malignant hematological diseases after autologous hematopoietic stem cell transplantation

Interventions

Group Romiplostim N01:Romiplostim No1 Treatment

Sponsors

The first affiliated hostipal of nanchang university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who are receiving autologous hematopoietic stem cell transplantation for malignant hematological diseases (including multiple myeloma, lymphoma, and acute leukemia with good prognosis); 2. Weight >=30kg, regardless of age or gender; 3. ECOG score <=1; 4. Patients is eligible for follow-up; 5. Patients without serious functional damage of major organs was found in the whole body; 6. Patients voluntarily sign informed consent forms.

Exclusion criteria

Exclusion criteria: 1.Have serious organ dysfunction or disease, such as heart, liver, kidney, pancreas and other serious disease and dysfunction; 2.Patients who cannot tolerate subcutaneous injections of Romiplostim N01; 3.Any life-threatening disease, medical condition, or organ system dysfunction that the investigator believes could compromise the safety of the subject or put the results of the study at unnecessary risk; 4.Patients who was drug dependent or uncontrolled mental illness or with cognitive disabilities; 5.Joined other similar clinical investigators within 3 months; 6.Other conditions not suitable for inclusion evaluated by the investigator (such as patients who are expected to be unable to adhere to treatment due to financial problems, etc.).

Design outcomes

Primary

MeasureTime frame
The time of platelet engraftment;

Secondary

MeasureTime frame
Platelet engraftment rate within 28 days after transplantation;Platelet transfusion volume;The occurrence situation of adverse events and serious adverse events;Incidence and severity of bleeding events;The incidence rate of secondary thrombocytopenia events during the follow-up period;Overall survival;Progression free survival;Disease free survival;Obejctive response rate;

Countries

China

Contacts

Public ContactFei Li

The first affiliated hostipal of nanchang university

691058841@qq.com+86 791 88692201

Outcome results

None listed

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