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

Study acronym: FRIENDS-01
StatusRecruiting
PhasePhase 3
Started2025-02-24
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 14, 2026 (before its estimated April 21, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-04-09
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-01-21→confirmed 2025-02-24
Eligibility criteria+343 characters
[...] therapy, immunology, and targeting; 4.ECOG PS score: 0-2; 5.CTITDeveloped patientstreatment-induced needthrombocytopenia twowith platelet testscount between 10×10⁹/L and 75×10⁹/L; if platelet count is between 10×10⁹/L and 50×10⁹/L, one platelet test is required with a 24-hour interval; if platelet count is between 50×10⁹/L and 75×10⁹/L, two platelet tests shouldare be performed 24 hours apart, and the platelet value should be between 10×10^9/L - 75×10^9/Lrequired.; 6.Estimated survival time during screening is ≥ 12 weeks, [...] ≥ 1.5ULN or eGFR ≤ 60 ml/min (Cockcroft Gault formula); 13.Within the f [...] [...]
Study sitesdetails revised at 1 of 1 site
Study title-56 characters
FRIENDS-01:A Multicenter Open-label Randomized Controlled Study on the Treatment of CTIT of the Efficacy and Safety W [...]
2024-12-29
minor
Original filing
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
Trial Details
NCT Number NCT06759636
Lead Sponsor The First Affiliated Hospital with Nanjing Medical University
Conditions CTIT: Cancer Therapy Induced Thrombocytopenia
Enrollment 88 participants
Start Date 2025-02-24
Primary Completion 2026-04-21 (estimated)
Study Completion 2026-07-21 (estimated)
Updated on ClinicalTrials.gov 2026-04-14