Lusutrombopag Combined With Recombinant Human Thrombopoietin for the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Destined to Undergo Elective Invasive Surgery: a Prospective, Multicentre, Single-arm Clinical Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To assess the efficacy and safety of lusutrombopag combined with recombinant human thrombopoietin for the treatment of thrombocytopenia in patients with chronic liver disease destined to undergo elective invasive surgery.

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

• Ability to understand the study and willingness to comply with all study procedures by voluntarily signing an informed consent form prior to screening.

• Male or female, 18 years of age or older at the time of signing the informed consent form.

• Patients with chronic liver disease.

• Baseline platelet count ≤ 35 x 109/L prior to enrolment on day 1.

• Proposed elective invasive surgery that meets the following conditions: - Platelet transfusion may be required - Expected to be performed between days 9 and 15 after enrolment - Excludes extremely high-risk surgical operations such as open abdomen, open chest, open skull, and direct cardiac surgery.

• Eastern Collaborative Oncology Group (ECOG) Physical Status (PS) score of 0 or 1.

• According to the researcher, it will be able to fulfil the requirements of this study.

• Male patients who are infertile or who agree to use adequate contraception (including the use of condoms containing spermicides) from the start of screening until completion of the post-treatment phase.

• Female patients who are not menopausal or surgically sterilised need to agree to the use of highly effective contraception (including implants, injectable contraception, combined hormonal contraception \[including vaginal rings\], intrauterine devices, or partner-performed vasectomies) from the start of the screening until the completion of the end-of-treatment phase. The use of barrier contraception with or without spermicide, double barrier contraception and oral contraceptives alone is not adequate.

Locations
Other Locations
China
No.2 People's Hospital of Fuyang city
RECRUITING
Fuyang
Anhui province hospital
RECRUITING
Hefei
Contact Information
Primary
Ji-Zhou Wang
wangjoe@ustc.edu.cn
+86 13836135864
Time Frame
Start Date: 2024-11-10
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 60
Treatments
Experimental: Treatment group
Lusutrombopag combined with recombinant human thrombopoietin
Related Therapeutic Areas
Sponsors
Leads: Anhui Provincial Hospital

This content was sourced from clinicaltrials.gov