Topical rhThrombin as an Adjunct to Hemostasis During Segmental Hepatectomy

Hepatectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611426
• Other study ID #: ZGrhT001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 29, 2017
• Est. completion date: July 30, 2019

Study information

• Verified date: October 2019
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 30, 2019
• Est. primary completion date: December 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male and female subjects between 18 and 75 years of age;

2. Hepar wedge resection or anatomic hepatectomy(one to five continue hepatic segments) (remark:including open surgery or hand-assisted laparoscopic surgery,patients who has been cholecystectomy or choledochotomy can be also get into the study);

3. Blood routine(including WBC?ANC?RBC?Hb and PLT) and Liver function(ALT=1.5ULN?AST=1.5ULN) is appear normal. ALP?LDH? TBil?Dbil are normal.(Remark: Patients whose Laboratory tests are abnormal but they are no clinical significance can get into the study);

4. Renal function(including Cr?BUN)?coagulation function(including PT?APTT?TT?INR)? electrolytes(include K?Na?CL?Ca?P?Mg)and electrocardiogram are normal or anormal.Investigator think they make no difference to operation;

5. No other therapeutic surgery was performed in the first 4 weeks before the subject gets into clinical research the study(in addition to diagnostic surgery).

6. Patients have not used blood products in 24hours before surgery.

7. Meet the requirements of the ethics committee.Sign the informed consent form and visited according to the protocol.

Exclusion Criteria:

1. Blood system diseases are known, including coagulopathy or bleeding tendency;

2. Life signs were not stable for more than 24hours;

3. Severe heart?brain and blood vessel diseases in past 6 months,including TIA?Non-disabling cerebral infarction?myocardial infarction?unstable angina or Intracranial hemorrhage;

4. Using the drugs that have an effect on blood coagulation in 7 days before surgey(including but not limited to: aspirin?clopidogrel?ticlopidine?dipyridamole?ginkgo biloba extract?heparin?warfarin?citrates?hemocoagulase?VitK?ethamsylate and Vitc,etc);

5. Complicated with other serious diseases(active infections,uncontrolled diabetes and hyperthyroidism);

6. Be allergic to thrombin(human)?serum(snake) and proteins (hamster);

7. Female subjects are in lactation or serum pregnancy test are positive;

8. Take part in other clinical trail within 4 weeks before geting into the study;

9. Using the Thrombin products and Antithrombin antibodies or Coagulation V factor antibodies are positive before, after using rhthrombin, it may generate an immune response.

Related Conditions & MeSH terms

• Hepatectomy

Intervention

Drug:
• rhThrombin ( Topical )
Active Substance
• placebo
saline solution

Locations

Country	Name	City	State
China	Zhiwei Li	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and Severity of adverse events	Incidence and Severity of adverse events	baseline to 4 weeks
Secondary	Proportion of Subjects Achieving Hemostasis by Six Minutes After Treatment Start	Subjects achieving hemostasis at the target bleeding site by 6 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure	From start of treatment until 6 minutes after treatment start
Secondary	The hemostatic time of the woud	The hemostatic time of the woud	From start of treatment until 6 minutes after treatment start
Secondary	immunogenicity	Incidence of rhThrombin antibody and Confirm whether they are neutralizing antibody	baseline to 4 weeks