NCT03270735

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 1, 2017

Status Verified

June 1, 2017

Enrollment Period

12 months

First QC Date

June 9, 2017

Last Update Submit

August 31, 2017

Conditions

Hemoptysis

Outcome Measures

Primary Outcomes (1)

  • AEs and SAEs

    The incidence of AEs and SAEs

    7 days

Secondary Outcomes (1)

  • Effective rate of treating hemoptysis

    72 hours

Study Arms (2)

Treatment

EXPERIMENTAL

Snake venom thrombin

Drug: Snake venom thrombin (Treatment)

Placebo

PLACEBO COMPARATOR

Snake venom thrombin simulant

Drug: Placebo

Interventions

Snake venom thrombin (Treatment)DRUG

Snake venom thrombin

Also known as: Snake venom thrombin
Treatment
PlaceboDRUG

No snake venom thrombin

Also known as: Snake venom thrombin simulant
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • INR\>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)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital Chinese Academy of Medical Sciences

Beijing, 100037, China

RECRUITING

MeSH Terms

Conditions

Hemoptysis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Central Study Contacts

Nan Yang, MD, PhD

CONTACT

852-23146533nancy.yang@leespharm.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2017

First Posted

September 1, 2017

Study Start

June 6, 2017

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

September 1, 2017

Record last verified: 2017-06

Locations

CN(1)