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rhThrombin is a serine protease from human.The study is to assess the Safety, Tolerability, Immunogenicity and efficacy of rhThrombin.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhThrombin ( Topical ) | Experimental | Cohort 1:rhThrombin ( Topical ) 500IU /ml、1000IU/m and 2000IU/ml During segmental hepatectomy; Cohort 2:rhThrombin ( Topical ) 1000IU/m and 2000IU/ml with absorbable collagen sponge During segmental hepatectomy; Cohort 3:rhThrombin ( Topical ) 1000IU/m and 2000IU/ml used directly sprayed on hemorrhagic point During segmental hepatectomy; |
|
| placebo | Placebo Comparator | Cohort 1: the same volume of saline during segmental hepatectomy; Cohort 2:the same volume of saline used withabsorbable collagen sponge during segmental hepatectomy; Cohort 3:the same volume of saline during segmental hepatectomy; |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhThrombin ( Topical ) | Drug | Active Substance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of adverse events | Incidence and Severity of adverse events | baseline to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhiwei Li, PhD | The First Affiliated Hospital of Medical School of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhiwei Li | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| C513462 | recombinant human thrombin |
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The first part is ascending dose study: 3 subjects take rhThromb and 1 subjects take the same volume of saline; The second part is dose extension study:2 cohorts and 1 blank control group( the same volume of saline) used with absorbable collagen sponge;every group need 12 subject; The second part is dose extension study: 2 cohorts and 1 blank control group( the same volume of saline);every group need 12 subject;
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| placebo | Drug | saline solution |
|
|
| The hemostatic time of the woud |
The hemostatic time of the woud |
| From start of treatment until 6 minutes after treatment start |
| immunogenicity | Incidence of rhThrombin antibody and Confirm whether they are neutralizing antibody | baseline to 4 weeks |