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

Hemoptysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03270735
• Other study ID #: 2016-ZK-003
• Status: Recruiting
• Phase: Phase 4
• First received: June 9, 2017
• Last updated: August 31, 2017
• Start date: June 6, 2017
• Est. completion date: December 2018

Study information

• Verified date: June 2017
• Source: Lee's Pharmaceutical Limited
• Contact: Nan Yang, MD, PhD
• Phone: 852-23146533
• Email: nancy.yang[@]leespharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 (??®), injection spearhead haemocoagulase (???®), Haemocoagulase Agkistrodon for Injection (??®), Hemocoagulase Atrox for Injection (???®), 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.

Related Conditions & MeSH terms

• Hemoptysis

Intervention

Drug:
• Snake venom thrombin (Treatment)
Snake venom thrombin
• Placebo
No snake venom thrombin

Locations

Country	Name	City	State
China	Fuwai Hospital Chinese Academy of Medical Sciences	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited	Zhaoke Pharmaceutical (Hefei) Company Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEs and SAEs	The incidence of AEs and SAEs	7 days
Secondary	Effective rate of treating hemoptysis	Effective rate of treating hemoptysis 72 hours after administration	72 hours