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Safety and Efficacy of Topical Recombinant Human Thrombin(rhThrombin) for Surgical Hemostasis

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ClinicalTrials.gov Identifier: NCT04459871
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary:
A multicenter, stratified randomized, double-blind, placebo-controlled, phase 3 clinical trial.

Condition or disease Intervention/treatment Phase
Surgical Hemostasis Biological: recombinant human Thrombin(CHO cell) Biological: placebo Phase 3

Detailed Description:

After establishing eligibility, subjects will be randomized in a 2:1 ratio to receive rhThrombin (1000 U/mL) or placebo. During a surgical procedure, study participants will be treated with blinded study drug (rhThrombin or placebo) in combination with an absorbable gelatin sponge at appropriate bleeding evaluation site(s). 510 patients will participate in the study.

In this study, stratified random enrollment was conducted according to the condition(experimental group or control group) of the subjects.Stratification factors were centered, gender (male/female) and age (18 ≤ age <60/60 ≤ age ≤70).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Stratified Randomized, Double-blind, Placebo-controlled Study of Topical Recombinant Human Thrombin (rhThrombin) in Surgical Hemostasis
Actual Study Start Date : November 8, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: The experimental group
The topical recombinant human thrombin(rhThrombin) was prepared into 1000IU/mL solution with 10ml normal saline and used in combination with absorbable gelatin spongeat at appropriate bleeding evaluation site(s).
Biological: recombinant human Thrombin(CHO cell)
2 rhThrombin, dissolved in 5mL sterile saline and mixed, the final solution contains 1000IU/mL rhThrombin solution (clear and transparent liquid).
Other Name: rhThrombin

Placebo Comparator: The control group
The placebo was prepared into a solution with 10mL normal saline and used in combination with absorbable gelatin sponge at appropriate bleeding evaluation site(s).
Biological: placebo
placebo, dissolved in 5mL sterile saline and mixed, the final solution contains 1000IU/mL rhThrombin solution (clear and transparent liquid).




Primary Outcome Measures :
  1. The rate of complete hemostasis within 6 minutes. [ Time Frame: 6 minutes ]
    Those who did not stop bleeding within 6 minutes were defined as treatment failure.


Secondary Outcome Measures :
  1. Incidence of adverse events(AE) [ Time Frame: Up to 28 days ]
    An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment.

  2. Time to Hemostasis(TTH) [ Time Frame: Evaluate the effect of hemostasis every 30sec until hemostasis is completed or 6 minutes of observation is completed ]
    TTH will be assessed for up to 6 minutes

  3. Immunogenicity [ Time Frame: At baseline and Day 29 ]
    Positive rate of anti-recombinant human thrombin neutralizing antibody.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 70 years old (including 18 and 70 years old), male or female;
  • Patients with wedge-shaped liver resection or anatomical liver resection(1-5 consecutive liver segments);
  • After the operation was controlled by standard surgical hemostasis, there were still patients with mild/moderate bleeding lesions (bleeding, non-arterial bleeding);
  • Electrolytes (K, Na, CL, Ca, P, Mg) and ECG are normal or abnormal, Investigators believe that patients who do not affect surgery
  • No other therapeutic surgery within 4 weeks before enrollment;
  • Patients who have not used blood products within 24 hours before surgery;
  • In compliance with the requirements of the ethics committee, patients voluntarily signed informed consent and were able to conduct visits as required by the protocol.

Exclusion Criteria:

  • Known diseases of the blood system, including patients with coagulopathy or bleeding tendency;
  • Patients with unstable vital signs for more than 24 hours;
  • A history of severe heart, brain, and vascular disease within 6 months, including patients with a history of TIA, non-disabling cerebral infarction, myocardial infarction, unstable angina, or intracranial hemorrhage;
  • Active bleeding or abnormal coagulation function (PT>16s, APTT>43s, INR≥2) or receiving thrombolysis, anticoagulation or antiplatelet therapy;
  • Have used drugs that affect the function of the coagulation system within 1 week before surgery (including but not limited to: aspirin, clopidogrel, ticlopidine, fensulfamide, desmopressin, aminotoluic acid, dipyridamole, ginkgo Leaf preparations, heparin, warfarin, citrate, hemagglutinin, Vk, anti-fibrotic solvents, hemostatic, Vc, etc.);
  • Women during pregnancy and lactation;
  • Participants who participated in clinical trials of other drugs within 4 weeks before enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459871


Contacts
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Contact: Sheng Yan, PhD 13957161680 shengyan@zju.edu.cn

Locations
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China, Zhejiang
The First Affiliated Hospital, Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China
Contact: Sheng Yan, PhD    86-13957161680    shengyan@zju.edu.cn   
Sponsors and Collaborators
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Investigators
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Principal Investigator: Sheng Yan, PhD The First Affiliated Hospital, Zhejiang University School of Medicine
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Responsible Party: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT04459871    
Other Study ID Numbers: ZGrhT002
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: June 2020

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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:
hepatic resection
rhThrombin,topical
Additional relevant MeSH terms:
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Thrombin
Hemostatics
Coagulants