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

Phase 4

• Conditions: Hemoptysis
• Interventions: Drug: Snake venom thrombin (Treatment); Drug: Placebo

• Registration Number: NCT03270735
• Lead Sponsor: Lee's Pharmaceutical Limited

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-06
• Study Start: 2017-06-06
• Study First Submitted: 2017-06-09
• Study First Submitted QC: 2017-08-31
• Last Update Submitted: 2017-08-31
• Study First Posted: 2017-09-01
• Last Update Posted: 2017-09-01
• Primary Completion: 2018-06
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

  1. INR>2
  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)
  3. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Snake venom thrombin (Treatment)	Snake venom thrombin
Placebo	Placebo	Snake venom thrombin simulant

Primary Outcome Measures

Name	Time	Method
AEs and SAEs	7 days	The incidence of AEs and SAEs

Secondary Outcome Measures

Name	Time	Method
Effective rate of treating hemoptysis	72 hours	Effective rate of treating hemoptysis 72 hours after administration

Trial Locations

Locations (1)

Fuwai Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China