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Topical rhThrombin as an Adjunct to Hemostasis During Segmental Hepatectomy

Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT03611426
Collaborator
(none)
84
Enrollment
1
Location
2
Arms
20
Actual Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: rhThrombin ( Topical )
  • Drug: placebo
 Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
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;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;
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 29, 2017
Actual Primary Completion Date :
Dec 5, 2018
Actual Study Completion Date :
Jul 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: rhThrombin ( Topical )

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;

Drug: rhThrombin ( Topical )
Active Substance
Other Names:
  • Recombinant Human Thrombin (CHO Cell) for Topical Use

    		•
    Placebo Comparator: placebo

    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;

    Drug: placebo
    saline solution
    Other Names:
  • PLA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence and Severity of adverse events [baseline to 4 weeks]

      Incidence and Severity of adverse events

    Secondary Outcome Measures

    1. Proportion of Subjects Achieving Hemostasis by Six Minutes After Treatment Start [From start of treatment until 6 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

    2. The hemostatic time of the woud [From start of treatment until 6 minutes after treatment start]

      The hemostatic time of the woud

    3. immunogenicity [baseline to 4 weeks]

      Incidence of rhThrombin antibody and Confirm whether they are neutralizing antibody

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhiwei Li Hangzhou Zhejiang China 310000

    Sponsors and Collaborators

    • Suzhou Zelgen Biopharmaceuticals Co.,Ltd

    Investigators

    • Principal Investigator: Zhiwei Li, PhD, The First Affiliated Hospital of Medical School of Zhejiang University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Suzhou Zelgen Biopharmaceuticals Co.,Ltd
    ClinicalTrials.gov Identifier:
    NCT03611426
    Other Study ID Numbers:
    • ZGrhT001
    First Posted:
    Aug 2, 2018
    Last Update Posted:
    Apr 14, 2021
    Last Verified:
    Oct 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Suzhou Zelgen Biopharmaceuticals Co.,Ltd
    Serine protease
    Tolerance
    Immunogenicity
    Safety
    Additional relevant MeSH terms:
    Thrombin

    Study Results

    No Results Posted as of Apr 14, 2021