A Clinical Study to Evaluate the Efficacy and Safety of Hemocoagulase Injection

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hemoptysis

Intervention / Treatment
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* Drug: Snake venom thrombin (Treatment)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Snake venom thrombin | Drug: Snake venom thrombin (Treatment)<br>* Snake venom thrombin<br>* Other names: Snake venom thrombin;|
| Placebo Comparator: Placebo<br>Snake venom thrombin simulant | Drug: Placebo<br>* No snake venom thrombin<br>* Other names: Snake venom thrombin simulant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs and SAEs | The incidence of AEs and SAEs | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective rate of treating hemoptysis | Effective rate of treating hemoptysis 72 hours after administration | 72 hours |