NCT06759636

A Study on the Treatment of CTIT of the Efficacy and Safety With Romiplostim N01 Compared to Recombinant Human Interleukin-11

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• CTIT: Cancer Therapy Induced Thrombocytopenia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-02-24
• Primary completion: 2026-04-21
• Completion: 2026-07-21
• First posted: 2025-01-06
• Last updated: 2026-04-14

Locations

1 site across 1 country: China