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NOT YET RECRUITING
NCT06759636
PHASE3

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

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2025-01-21

Completion Date

2026-07-21

Last Updated

2025-01-06

Healthy Volunteers

No

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

Locations (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China