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Status unknownNCT03270735Updated Sep 1, 2017

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

A Phase 4 interventional study of Snake venom thrombin (Treatment) and Placebo in Hemoptysis, sponsored by Lee's Pharmaceutical Limited. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-09-01.

Sponsored by Lee's Pharmaceutical Limited · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hemoptysis

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03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Treatment

    Snake venom thrombin

    Drug: Snake venom thrombin (Treatment)

  • Placebo comparator
    Placebo

    Snake venom thrombin simulant

    Drug: Placebo

Interventions

  • DrugSnake venom thrombin (Treatment)

    Snake venom thrombin

    Also known as: Snake venom thrombin

  • DrugPlacebo

    No snake venom thrombin

    Also known as: Snake venom thrombin simulant

05

What researchers measure

Primary outcomes

  1. AEs and SAEs

    The incidence of AEs and SAEs

    Time frame: 7 days

Secondary outcomes

  1. Effective rate of treating hemoptysis

    Effective rate of treating hemoptysis 72 hours after administration

    Time frame: 72 hours

06

Study locations

1 of 1 sites recruiting
  • Fuwai Hospital Chinese Academy of Medical Sciences
    Beijing, 100037, China
    Recruiting
07

Registry details

Key details

Study ID
NCT03270735
Lead sponsor
Lee's Pharmaceutical Limited
Collaborators
Zhaoke Pharmaceutical (Hefei) Company Limited
Responsible party
Sponsor
First posted
Sep 1, 2017
Start date
Jun 6, 2017
Primary completion
Jun 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Sep 1, 2017

Study contacts

Nan Yang, MD, PhD
Contact
nancy.yang@leespharm.com
852-23146533

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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