HemoptysisPhase 4NCT03270735
A Clinical Study to Evaluate the Efficacy and Safety of Hemocoagulase Injection
A Phase 4 study testing Snake venom thrombin (Treatment) in people with Hemoptysis, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemoptysis
- What is being tested?
- Snake venom thrombin (Treatment)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2017to Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital Chinese Academy of Medical Sciences
Beijing, 100037
Yuhui Zhang, MD, 86-10-88322674, yuhuizhangjoy@163.com
About this study
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
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.
- Conditions
- Hemoptysis
- Being tested
- Snake venom thrombin (Treatment), Placebo
- Medical subject headings
- Hemoptysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snake venom thrombin (Treatment)Drug
Also called Snake venom thrombin
Snake venom thrombin
PlaceboDrug
Also called Snake venom thrombin simulant
No snake venom thrombin
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Snake venom thrombin Receives: Drug: Snake venom thrombin (Treatment) |
| Placebo | Placebo comparator | Snake venom thrombin simulant Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs and SAEs
The incidence of AEs and SAEs
Measured: 7 days
Secondary outcomes (1)
Effective rate of treating hemoptysis
Effective rate of treating hemoptysis 72 hours after administration
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start6 Jun 2017
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemoptysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zhaoke Pharmaceutical (Hefei) Company Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270735
- Sponsor's protocol ID
- 2016-ZK-003
- Status last verified
- Jun 2017
- First submitted
- 9 Jun 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03270735
- Acronym / sponsor ID
- 2016-ZK-003
- Conditions
- Hemoptysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Zhaoke Pharmaceutical (Hefei) Company Limited
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Snake venom thrombin (Treatment)Snake venom thrombin |
| Placebo | Placebo comparator | Drug: PlaceboSnake venom thrombin simulant |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Snake venom thrombin (Treatment)Also: Snake venom thrombinSnake venom thrombin | Drug | Treatment |
| PlaceboAlso: Snake venom thrombin simulantNo snake venom thrombin | Drug | Placebo |
Primary outcome
AEs and SAEs
Time frame: 7 days
The incidence of AEs and SAEs
1 secondary outcome
Effective rate of treating hemoptysis
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Snake venom thrombin (Treatment) in people with Hemoptysis, run by Lee's Pharmaceutical Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nan Yang, MD, PhD (852-23146533, nancy.yang@leespharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs and SAEs (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.