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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03611426
Other study ID # ZGrhT001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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