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Romiplostim N01 for Chemotherapy-induced Thrombocytopenia

NCT07063225 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-07-14

No results posted yet for this study

Summary

To evaluate the efficacy and safety of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia in tumors

Conditions

  • Chemotherapy-induced Thrombocytopenia
  • Romiplostim N01

Interventions

DRUG

Romiplostim N01

The subjects will receive ropivacaine N01 treatment, with an initial dose of (2-3) µg/kg. When the dose is less than 250 µg, 250 µg (1 vial) can be administered (subcutaneously), once a week. The dose will be increased by (1) µg/kg each week, up to a maximum of 10 µg/kg, until the platelet count reaches ≥ 50 × 10\^9/L. If the platelet count returns to normal, the dose can be reduced according to the platelet level as appropriate.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    collaborator OTHER

  • Tianjin Medical University Second Hospital

    collaborator OTHER

  • Tianjin Third Central Hospital

    collaborator OTHER

  • Tianjin People's Hospital

    collaborator OTHER

  • Henan Cancer Hospital

    collaborator OTHER_GOV

  • The Second Affiliated Hospital of Kunming Medical University

    collaborator OTHER

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Principal Investigators

  • Yunfei Chen, MD · Chinese Academy of Medical Science and Blood Disease Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07063225 on ClinicalTrials.gov