NCT03611426

Topical rhThrombin as an Adjunct to Hemostasis During Segmental Hepatectomy

A Randomized，Ascending Dose，Single-blind Phase 1&2 Study to Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of Topical rhThrombin as an Adjunct to Hemostasis During Segmental Hepatectomy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

rhThrombin is a serine protease from human.The study is to assess the Safety, Tolerability, Immunogenicity and efficacy of rhThrombin.

Detailed description

The study is a randomized, single-blind,blank controlled phase 1\&2 trial ,including 3 independent parts toevaluate the safety,efficacy and immunogenicity. The first part is ascending dose,blank control tolerability and safety study. The Starting doses from 500IU/ml to 1000IU/mL and 2000IU/mL to evaluate the safety,efficacy. The second part is randomized, single-blind, blank controlled study to evaluate safety、efficacy and immunogenicity. Doses settings :1000IU/mL , 2000IU/mL and blank group which with absorbable collagen sponge when used. The third part is randomized, single-blind, blank controlled study to evaluate safety、efficacy and immunogenicity. Doses settings :1000IU/mL , 2000IU/mL and blank group which directly sprayed on hemorrhagic point when used.

Conditions

• Hepatectomy

Interventions

Type	Name	Description
DRUG	rhThrombin ( Topical )	Active Substance
DRUG	placebo	saline solution

Timeline

• Start date: 2017-11-29
• Primary completion: 2018-12-05
• Completion: 2019-07-30
• First posted: 2018-08-02
• Last updated: 2021-04-14

Locations

1 site across 1 country: China