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| Name | Class |
|---|---|
| Zhaoke Pharmaceutical (Hefei) Company Limited | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Snake venom thrombin |
|
| Placebo | Placebo Comparator | Snake venom thrombin simulant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Snake venom thrombin (Treatment) | Drug | Snake venom thrombin |
|
| Measure | Description | Time Frame |
|---|---|---|
| AEs and SAEs | The incidence of AEs and SAEs | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Effective rate of treating hemoptysis | Effective rate of treating hemoptysis 72 hours after administration | 72 hours |
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Inclusion Criteria:
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
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nan Yang, MD, PhD | Contact | 852-23146533 | nancy.yang@leespharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | 100037 | China |
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| ID | Term |
|---|---|
| D006469 | Hemoptysis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Placebo | Drug | No snake venom thrombin |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |