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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hemoptysis
• Intervention / Treatment: Drug: Snake venom thrombin (Treatment); Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Nan Yang, MD, PhD; Phone Number: 852-23146533; Email: nancy.yang@leespharm.com

Study Locations

• China
  • Beijing, China, 100037
    • Recruiting
    • Fuwai Hospital Chinese Academy of Medical Sciences
    • Contact: Yuhui Zhang, MD; Phone Number: 86-10-88322674; Email: yuhuizhangjoy@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Snake venom thrombin	Drug: Snake venom thrombin (Treatment); Snake venom thrombin; Other Names: Snake venom thrombin
Placebo Comparator: Placebo; Snake venom thrombin simulant	Drug: Placebo; No snake venom thrombin; Other Names: Snake venom thrombin simulant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs and SAEs	The incidence of AEs and SAEs	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective rate of treating hemoptysis	Effective rate of treating hemoptysis 72 hours after administration	72 hours

Collaborators and Investigators

• Sponsor: Lee's Pharmaceutical Limited
• Collaborators: Zhaoke Pharmaceutical (Hefei) Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2017
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: June 9, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): September 1, 2017
• Last Update Submitted That Met QC Criteria: August 31, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Hemorrhage; Signs and Symptoms, Respiratory; Hemoptysis; Hemostatics; Coagulants; Thrombin
• Other Study ID Numbers: 2016-ZK-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No