Romiplostim N01 for Chemotherapy-induced Thrombocytopenia in Tumors: a Prospective Multi-center One-arm Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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;

• Patients with platelet count remains \< 30×10\^9/L for more than 1 month;

• Patients with expected survival period ≥ 6 months;

• Patients with liver and kidney function \< 1.5× upper limit of normal value, physical examination qualified;

• Patients with ECOG physical status score ≤ 2 points;

• Patients with Cardiac function: New York Heart Association cardiac function classification is grade 2 or below;

• Patients who is voluntary to sign the informed consent form;

Locations
Other Locations
China
Chinese Academy of Medical Science and Blood Disease Hospital
RECRUITING
Tianjin
Contact Information
Primary
Ting Sun, MD
sunting@ihcams.ac.cn
+8615822339131
Backup
Yunfei Chen, MD
henyunfei@ihcams.ac.cn
8618502220788
Time Frame
Start Date: 2025-08
Estimated Completion Date: 2026-08
Participants
Target number of participants: 50
Treatments
Experimental: Romiplostim N01
50 enrolled subjects will be picked up to take Romiplostim N01 at the indicated dose.
Related Therapeutic Areas
Sponsors
Collaborators: Tianjin Third Central Hospital, The Second Affiliated Hospital of Kunming Medical University, Henan Cancer Hospital, Tianjin People's Hospital, Tianjin Medical University Cancer Institute and Hospital, Tianjin Medical University Second Hospital
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov