FRIENDS-01:A Multicenter Open-label Randomized Controlled Study on the Treatment of CTIT of the Efficacy and Safety With Romiplostim N01 Compared to Recombinant Human Interleukin-11

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

January 21, 2025

Primary Completion Date

April 21, 2026

Study Completion Date

July 21, 2026

Conditions
CTIT: Cancer Therapy Induced Thrombocytopenia
Interventions
DRUG

Romiplostim N01

3.0 µg/kg, subcutaneous injection, once a week. Afterwards, refer to the platelet count evaluated during the visit before the next dosing cycle: ① If the platelet count is less than 50×10\^9/L, increase by 1-2μg/kg once a week; ② If the platelet count is between 50-99×10\^9/L, increase by 1μg/kg once a week. According to platelet count and symptoms, investigators can adjust the dosage to the maximum dosage of 10μg/kg once a week.

DRUG

Recombinant Human Interleukin-11 (rhIL-11)

25-50μg/kg, subcutaneous injection, once a day

Trial Locations (1)

210000

The First Affiliated Hospital with Nanjing Medical University, Nanjing

All Listed Sponsors
lead

The First Affiliated Hospital with Nanjing Medical University

OTHER