NCT04459871

Safety and Efficacy of Topical Recombinant Human Thrombin(rhThrombin) for Surgical Hemostasis

A Phase 3, Stratified Randomized, Double-blind, Placebo-controlled Study of Topical Recombinant Human Thrombin (rhThrombin) in Surgical Hemostasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 348 (actual)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, stratified randomized, double-blind, placebo-controlled, phase 3 clinical trial.

Detailed description

After establishing eligibility, subjects will be randomized in a 2:1 ratio to receive rhThrombin (1000 U/mL) or placebo. During a surgical procedure, study participants will be treated with blinded study drug (rhThrombin or placebo) in combination with an absorbable gelatin sponge at appropriate bleeding evaluation site(s). 510 patients will participate in the study. In this study, stratified random enrollment was conducted according to the condition(experimental group or control group) of the subjects.Stratification factors were centered, gender (male/female) and age (18 ≤ age \<60/60 ≤ age ≤70).

Conditions

• Surgical Hemostasis

Interventions

Type	Name	Description
BIOLOGICAL	recombinant human Thrombin(CHO cell)	2 rhThrombin, dissolved in 5mL sterile saline and mixed, the final solution contains 1000IU/mL rhThrombin solution (clear and transparent liquid).
BIOLOGICAL	placebo	placebo, dissolved in 5mL sterile saline and mixed, the final solution contains 1000IU/mL rhThrombin solution (clear and transparent liquid).

Timeline

• Start date: 2019-11-11
• Primary completion: 2021-10-20
• Completion: 2021-10-20
• First posted: 2020-07-07
• Last updated: 2022-11-29

Locations

1 site across 1 country: China