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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShandong University

About this trial

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

Eligibility criteria

Qualifiers

Sign a written informed consent form before enrollment;

Age range from 18 to 75 years old;

Solid tumors or hematological tumors confirmed by tissue or pathology;

CTIT patients caused by anti-tumor therapy;

Disqualifiers

Suffering from hematopoietic system diseases other than thrombocytopenia (CIT) caused by tumor chemotherapy drugs, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome;

Screening for thrombocytopenia caused by causes other than CIT within the first 6 months, including but not limited to chronic liver disease, splenic hyperfunction, infection, and bleeding;

Bone marrow invasion or metastasis;

Have received pelvic and spinal radiation therapy, as well as bone field radiation therapy, or are currently/expected to receive radiation therapy within the three months prior to screening;

Trial design

Treatments tested in this trial

  • Romiplostim N01
  • Recombinant Human Thrombopoietin

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators