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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03270735

Enrollment

100

Registered

2017-09-01

Start date

2017-06-06

Completion date

2018-12-31

Last updated

2017-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemoptysis

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.

Interventions

DRUGSnake venom thrombin (Treatment)

Snake venom thrombin

DRUGPlacebo

No snake venom thrombin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
AEs and SAEs	7 days	The incidence of AEs and SAEs

Secondary

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

Countries

China

Contacts

Primary ContactNan Yang, MD, PhD

nancy.yang@leespharm.com852-23146533

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026