Clinical trial NCT03270735: A Clinical Study to Evaluate the Efficacy and Safety of Hemocoagulase Injection
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hemoptysis
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
Collaborators: name: Zhaoke Pharmaceutical (Hefei) Company Limited
First posted: 2017-09-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: AEs and SAEs
timeFrame: 7 days
Secondary outcomes:
measure: Effective rate of treating hemoptysis
timeFrame: 72 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital Chinese Academy of Medical Sciences
Study officials:
References: