Topical rhThrombin as an Adjunct to Hemostasis During Segmental Hepatectomy

NCT03611426 | Completed Phase 1

• 1 other identifier: ZGrhT001
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatectomy

Keywords

Serine protease; Tolerance; Immunogenicity; Safety

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of adverse events

  Incidence and Severity of adverse events

  baseline to 4 weeks

Secondary Outcomes (3)

• Proportion of Subjects Achieving Hemostasis by Six Minutes After Treatment Start

  From start of treatment until 6 minutes after treatment start

• The hemostatic time of the woud

  From start of treatment until 6 minutes after treatment start

• immunogenicity

  baseline to 4 weeks

Study Arms (2)

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;

Drug: rhThrombin ( Topical )

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;

Drug: placebo

Interventions

rhThrombin ( Topical ) DRUG

Active Substance

Also known as: Recombinant Human Thrombin (CHO Cell) for Topical Use

rhThrombin ( Topical )

placebo DRUG

saline solution

Also known as: PLA

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects between 18 and 75 years of age;
• 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);
• 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);
• 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;
• 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).
• Patients have not used blood products in 24hours before surgery.
• Meet the requirements of the ethics committee.Sign the informed consent form and visited according to the protocol.

You may not qualify if:

• Blood system diseases are known, including coagulopathy or bleeding tendency;
• Life signs were not stable for more than 24hours;
• Severe heart、brain and blood vessel diseases in past 6 months,including TIA、Non-disabling cerebral infarction、myocardial infarction、unstable angina or Intracranial hemorrhage;
• 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);
• Complicated with other serious diseases(active infections,uncontrolled diabetes and hyperthyroidism);
• Be allergic to thrombin(human)、serum(snake) and proteins (hamster);
• Female subjects are in lactation or serum pregnancy test are positive;
• Take part in other clinical trail within 4 weeks before geting into the study;
• Using the Thrombin products and Antithrombin antibodies or Coagulation V factor antibodies are positive before, after using rhthrombin, it may generate an immune response.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Zhiwei Li

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Interventions

recombinant human thrombin

Study Officials

• Zhiwei Li, PhD

  The First Affiliated Hospital of Medical School of Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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;

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 2, 2018
• Study Start: November 29, 2017
• Primary Completion: December 5, 2018
• Study Completion: July 30, 2019
• Last Updated: April 14, 2021

Record last verified: 2019-10

Locations

CN (1)