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

Lee's Pharmaceutical Limited1 site in 1 country100 target enrollmentJune 6, 2017

ConditionsHemoptysis

InterventionsSnake venom thrombin (Treatment)Placebo

DrugsSnake venom thrombin (Treatment)Placebo

Overview

Phase: Phase 4
Intervention: Snake venom thrombin (Treatment)
Conditions: Hemoptysis
Sponsor: Lee's Pharmaceutical Limited
Enrollment: 100
Locations: 1
Primary Endpoint: AEs and SAEs
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 6, 2017

End Date

December 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Lee's Pharmaceutical Limited

Responsible Party

Sponsor

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
•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;