Romiplostim N01 for Chemotherapy-induced Thrombocytopenia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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

Eligibility criteria

Qualifiers

Age: 18 years or above, gender not restricted;

Patients who meet the diagnostic criteria for chemotherapy-related thrombocytopenia, and still ineffective after repeated treatment with rhTPO or IL-11 (subjects need to undergo regular rhTPO treatment for at least 14 days after radiotherapy and chemotherapy, with a dose of rhTPO 300u/kg/d or higher, and the platelet count remains less than 30×10^9/L, defined as refractory CTIT);

Patients who have stopped chemotherapy and radiotherapy for more than 1 month;

Patients with platelet count at enrollment < 30×10^9/L;

Disqualifiers

Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases;

Patients with poor compliance;

Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;

Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc.

Trial design

Treatments tested in this trial

  • Romiplostim N01

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Collaborator

Tianjin Medical University Second Hospital

Collaborator

Tianjin Third Central Hospital

Collaborator

Tianjin People's Hospital

Collaborator

Henan Cancer Hospital

Collaborator

The Second Affiliated Hospital of Kunming Medical University

Collaborator