Thrombocytopenia Clinical Trials

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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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 1\. Voluntarily participate in this study, sign an informed consent form, and strictly complied with the study protocol requirements;

• 2.Age range from 18 to 75 years old,male or female;

• 3.Diagnosed with a malignant tumor by histopathology and/or cytology and is receiving anti-tumor therapy such as chemotherapy, radiotherapy, immunology, and targeting;

• 4.ECOG PS score: 0-2;

• 5.Developed treatment-induced thrombocytopenia with platelet count 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 are required.;

• 6.Estimated survival time during screening is ≥ 12 weeks, and could be treated with current antitumor regimens for at least 1 cycle;

• 7.Subjects of childbearing age agree to take reliable contraceptive measures (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive film, contraceptive cream, contraceptive suppository, abstinence and the placement of intrauterine devices, etc.) throughout the study period; Excluding female participants who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation, or more than 1 year after menopause, as well as male participants who have undergone bilateral salpingectomy or ligation;

• 8.Adequate organ and bone marrow function.

Locations
Other Locations
China
The First Affiliated Hospital with Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Xiaofeng Chen Xiaofeng Chen, Chief physician
xiaofengch198019@126.com
86+13585172066
Time Frame
Start Date: 2025-02-24
Estimated Completion Date: 2026-07-21
Participants
Target number of participants: 88
Treatments
Experimental: 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.
Active_comparator: Recombinant Human Interleukin-11
25-50μg/kg, subcutaneous injection, once a day
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov