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

Lee's Pharmaceutical

Status and phase: Unknown; Phase 4

Conditions: Hemoptysis

Treatments: Drug: Placebo; Drug: Snake venom thrombin (Treatment)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03270735

2016-ZK-003

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

Snake venom thrombin

Treatment:

Drug: Snake venom thrombin (Treatment)

Placebo

Placebo Comparator group

Description:

Snake venom thrombin simulant

Treatment:

Drug: Placebo