Status:
UNKNOWN
A Clinical Study to Evaluate the Efficacy and Safety of Hemocoagulase Injection
Lead Sponsor:
Lee's Pharmaceutical Limited
Collaborating Sponsors:
Zhaoke Pharmaceutical (Hefei) Company Limited
Conditions:
Hemoptysis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 hemopt...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03270735
Start Date
June 6 2017
End Date
December 1 2018
Last Update
September 1 2017
Active Locations (1)
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1
Fuwai Hospital Chinese Academy of Medical Sciences
Beijing, China, 100037