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

NCT ID: NCT03270735

Last Updated: 2017-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-06
• Study Completion Date: 2018-12-31

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.

Conditions

Hemoptysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment

Snake venom thrombin

Group Type: EXPERIMENTAL

Snake venom thrombin (Treatment)

Intervention Type: DRUG

Snake venom thrombin

Placebo

Snake venom thrombin simulant

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

No snake venom thrombin

Interventions

Snake venom thrombin (Treatment)

Snake venom thrombin

Intervention Type: DRUG

Placebo

No snake venom thrombin

Intervention Type: DRUG

Other Intervention Names

Snake venom thrombin; Snake venom thrombin simulant

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhaoke Pharmaceutical (Hefei) Company Limited

INDUSTRY

Sponsor Role: collaborator

Lee's Pharmaceutical Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fuwai Hospital Chinese Academy of Medical Sciences

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Nan Yang, MD, PhD

Role: CONTACT

nancy.yang@leespharm.com

852-23146533

Facility Contacts

Yuhui Zhang, MD

Role: primary

yuhuizhangjoy@163.com

86-10-88322674

Other Identifiers

2016-ZK-003

Identifier Type: -

Identifier Source: org_study_id