Back to resultsA Clinical Study to Evaluate the Efficacy and Safety of Hemocoagulase Injection
Primary Purpose
Hemoptysis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Snake venom thrombin (Treatment)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hemoptysis
Eligibility Criteria
Inclusion Criteria:
- 18-75 years;
- Hemoptysis >=100 mL within 24 hours;
- Bronchiectasis diagnosed by chest high resolution CT;
- Patient, family or guardian is willing to sign the informed consent form.
Exclusion Criteria:
- With severe hepatic or renal insufficiency, ALT>3 ULN, creatinine clearance <30 mL/min or serum creatinine ≥200 µmol/L or ≥2.5 mg/dL;
- Uncontrollable hypertension (SBP>180mmHg or DBP>110mmHg) or hypotension shock (SBP<90 mmHg) at randomization;
- History of thrombosis, patients who have undergone thrombosis, or who have severe hematologic diseases;
- Patient with bleeding caused by DIC or vascular disease;
Patient with coagulation dysfunction
- INR>2
- Patient with abnormal coagulation function or other bleeding disease (including clinical congenital bleeding disorders, such as von Willebrand disease or acquired hemophilia; hemorrhagic disease; and significant unexplained hemorrhagic disease)
- Platelet count <100×109 /L;
- known allergic to aspirin, clopidogrel, heparin, snake venom blood clotting enzyme, or any component in the study drug allergy or allergic constitution;
- Women who are pregnant or lactating and women of child-bearing agewho do not take reliable contraceptive measures;
- Patients who are or are planning to participate in other clinical trials during the study period;
- Within 72 hours before using the following products including Hemocoagulase For Injection (邦亭®), injection spearhead haemocoagulase (巴曲亭®), Haemocoagulase Agkistrodon for Injection (苏灵®), Hemocoagulase Atrox for Injection (立止血®), leaf pigment or other hemostatic agents;
- Life expectancy of less than 3 months;
- Any other patients who have been judged unfit to participate in this clinical study, including those who are unable or unwilling to comply with the protocol requirements;
- Patients who had participated in other clinical studies within three months prior to the study.
Sites / Locations
- Fuwai Hospital Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Placebo
Arm Description
Snake venom thrombin
Snake venom thrombin simulant
Outcomes
Primary Outcome Measures
AEs and SAEs
The incidence of AEs and SAEs
Secondary Outcome Measures
Effective rate of treating hemoptysis
Effective rate of treating hemoptysis 72 hours after administration
Full Information
NCT ID
NCT03270735
First Posted
June 9, 2017
Last Updated
August 31, 2017
Sponsor
Lee's Pharmaceutical Limited
Collaborators
Zhaoke Pharmaceutical (Hefei) Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT03270735
Brief Title
A Clinical Study to Evaluate the Efficacy and Safety of Hemocoagulase Injection
Official Title
A Multi-centre, Randomised, Double Blind, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Snake Venom Thrombin Injection in the Treatment of Moderate to Severe Hemoptysis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lee's Pharmaceutical Limited
Collaborators
Zhaoke Pharmaceutical (Hefei) Company Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a multi-centre, randomised, double blind, placebo controlled clinical study which is designed to evaluate the efficacy and safety of hemocoagulase in the treatment of moderate to severe hemoptysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemoptysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Snake venom thrombin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Snake venom thrombin simulant
Intervention Type
Drug
Intervention Name(s)
Snake venom thrombin (Treatment)
Other Intervention Name(s)
Snake venom thrombin
Intervention Description
Snake venom thrombin
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Snake venom thrombin simulant
Intervention Description
No snake venom thrombin
Primary Outcome Measure Information:
Title
AEs and SAEs
Description
The incidence of AEs and SAEs
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Effective rate of treating hemoptysis
Description
Effective rate of treating hemoptysis 72 hours after administration
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-75 years;
Hemoptysis >=100 mL within 24 hours;
Bronchiectasis diagnosed by chest high resolution CT;
Patient, family or guardian is willing to sign the informed consent form.
Exclusion Criteria:
With severe hepatic or renal insufficiency, ALT>3 ULN, creatinine clearance <30 mL/min or serum creatinine ≥200 µmol/L or ≥2.5 mg/dL;
Uncontrollable hypertension (SBP>180mmHg or DBP>110mmHg) or hypotension shock (SBP<90 mmHg) at randomization;
History of thrombosis, patients who have undergone thrombosis, or who have severe hematologic diseases;
Patient with bleeding caused by DIC or vascular disease;
Patient with coagulation dysfunction
INR>2
Patient with abnormal coagulation function or other bleeding disease (including clinical congenital bleeding disorders, such as von Willebrand disease or acquired hemophilia; hemorrhagic disease; and significant unexplained hemorrhagic disease)
Platelet count <100×109 /L;
known allergic to aspirin, clopidogrel, heparin, snake venom blood clotting enzyme, or any component in the study drug allergy or allergic constitution;
Women who are pregnant or lactating and women of child-bearing agewho do not take reliable contraceptive measures;
Patients who are or are planning to participate in other clinical trials during the study period;
Within 72 hours before using the following products including Hemocoagulase For Injection (邦亭®), injection spearhead haemocoagulase (巴曲亭®), Haemocoagulase Agkistrodon for Injection (苏灵®), Hemocoagulase Atrox for Injection (立止血®), leaf pigment or other hemostatic agents;
Life expectancy of less than 3 months;
Any other patients who have been judged unfit to participate in this clinical study, including those who are unable or unwilling to comply with the protocol requirements;
Patients who had participated in other clinical studies within three months prior to the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nan Yang, MD, PhD
Phone
852-23146533
Email
nancy.yang@leespharm.com
Facility Information:
Facility Name
Fuwai Hospital Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuhui Zhang, MD
Phone
86-10-88322674
Email
yuhuizhangjoy@163.com
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study to Evaluate the Efficacy and Safety of Hemocoagulase Injection
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