Acute Respiratory Distress SyndromePhase 2NCT02895191
The Safety and Dose Response Relationship of Ulinastatin for Acute Respiratory Distress Syndrome(ARDS)
A Phase 2 study testing ulinastatin in people with Acute Respiratory Distress Syndrome, run by Techpool Bio-Pharma Co., Ltd. at 11 sites in China.
Trial summary
Compared with placebo, evaluate the effects and safety of Ulinastatin(UTI) added to conventional treatment for ARDS; Evaluate the dose response relationship of Ulinastatin for ARDS. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- ulinastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 11 sitesChina
- Study dates
- Aug 2016to Dec 2019
- Phase
- Phase 2
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have provided signed written informed consent form (ICF) from the patient or the patient's legal representative;
- Male or Female patients ≥18 years of age;
- ARDS defined with using 2012 Berlin Criteria;
- ARDS diagnosed ≤7 days, and patients should be mechanically ventilated(invasive and or noninvasive mechanical ventilation); 5)100mmhg < PaO2/FiO2 < 250mmhg with CPAP/PEEP≥5 cmH2O;
Who cannot join
- Patient with known hypersensitivity to Ulinastatin/adjuvant or patient with allergic constitution;
- Patients with artificial organs replacement therapy for liver or kidney；
- Glasgow Coma Scale (GCS)≤8；
- Cardiogenic pulmonary edema , and the cardiogenic pulmonary edema is as the only or primary reason for respiratory failure;
- ARDS caused by burning, drowning, poisoning;
- Presence of severe chronic liver diseases (Child-Pugh score 12-15)，or severe chronic respiratory disease with a PaCO2 > 50 mmHg or the use of home oxygen;
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- Neutrophils<1.5×10^9/L
- Moribund patients (i.e.,expected to live no longer than 24 hours) or with recent (within 7days or anytime during present hospitalization) cardiopulmonary arrest;
- Patients need long-term glucocorticoid treatment or need to be treated with immunosuppressive drugs;
- No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol;
- Lung transplant patients;
- Patients with malignancy, expected to live no longer than 6 months;
- Pregnant or breast-feeding;
- Patients who have participated in any clinical study within 3 months prior to the screening;
- Any condition that in the opinion of the investigator would add the patient's risk or jeopardize the operation of the study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
West China Hospital,Sichuan Unversity
Chengdu, Sichuan, 610041
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Hainan General Hospital
Haikou, Hainan, 570311
Zhejiang Hospital
Hangzhou, Zhejiang, 310030
Lishui City People's Hospital
Lishui, Zhejiang, 323000
Huadong Hospital,Fudan University
Shanghai, Shanghai Municipality, 200040
Shanghai Sixth People's Hospital
Shanghai, Shanghia, 200233
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
About this study
Official title: A Randomized, Blind, Placebo-controlled, Parallel Group, Multi-center Study to Evaluate the Safety and Dose Response Relationship of Ulinastatin for Acute Respiratory Distress Syndrome(ARDS)
Compared with placebo, evaluate the effects and safety of Ulinastatin(UTI) added to conventional treatment for ARDS; Evaluate the dose response relationship of Ulinastatin for ARDS.
Read the detailed description
After signed off the informed consent form by patient or surrogate, and after completing the screening phase, the patients who fulfill the inclusion and exclusion criteria will be randomized 1:1:1:1 to the 4 study arms. All the Patients will receive the study treatment drugs for 7 to 14 days. Use Day 28 of last patient as a cut-off day, Collect the follow up visit data on both Day 28 and Day 90 of other patients．
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- ulinastatin, placebo
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ulinastatinDrug
Also called UTI, urinary trypsin inhibitor, bikunin
Patients will receive the study drugs for 7 to 14 days
placeboDrug
Patients will receive the placebo for 7 to 14 days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Cohort 1- Ulinastatin 4.8 million units per day Receives: Drug: ulinastatin |
| Cohort 2 | Experimental | Cohort 2- Ulinastatin 2.4 million units per day Receives: Drug: ulinastatin |
| Cohort 3 | Experimental | Cohort 3- Ulinastatin 1.2 million units per day Receives: Drug: ulinastatin |
| control group | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events(AEs) which can not excluded relatedness with study Product
Measured: Day 1 to Day 90
Secondary outcomes (9)
Changes of PaO2/FiO2 ratio
Measured: Day 0 and Day 1 to within 24h after the last treatment
Days alive and off ventilator
Measured: Day 1 to Day 28
Days in the ICU
Measured: Day 1 to Day 14
Changes of pulmonary compliance
Measured: Day 1 , Day 3 ,Day7 and within 24h after the last treatment
Rate of new organ failure
Measured: Day 1 to Day 90
Changes of APACHEⅡ Score from baseline
Measured: Day 3 ,Day7 and within 24h after the last treatment
Changes of Murray Lung Injury Score from baseline
Measured: Day 3 ,Day7 and within 24h after the last treatment
Changes of Sequential Organ Failure Assessment (SOFA) score from baseline
Measured: Day 3 ,Day7 and within 24h after the last treatment
All-cause mortality
Measured: Day 28 , Day 90 and Day 1 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Techpool Bio-Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yimin Li, Doctor, Principal investigator, First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895191
- Sponsor's protocol ID
- UTI-2001
- Status last verified
- Apr 2018
- First submitted
- 21 Jul 2016
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blind, Placebo-controlled, Parallel Group, Multi-center Study to Evaluate the Safety and Dose Response Relationship of Ulinastatin for Acute Respiratory Distress Syndrome(ARDS)
- ClinicalTrials.gov ID
- NCT02895191
- Acronym / sponsor ID
- UTI-2001
- Conditions
- Acute Respiratory Distress Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Techpool Bio-Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Guangzhou Medical University
- Study start
- Aug 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 9 Sep 2016 (estimated)
- 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.
Compared with placebo, evaluate the effects and safety of Ulinastatin(UTI) added to conventional treatment for ARDS; Evaluate the dose response relationship of Ulinastatin for ARDS.
Detailed description
After signed off the informed consent form by patient or surrogate, and after completing the screening phase, the patients who fulfill the inclusion and exclusion criteria will be randomized 1:1:1:1 to the 4 study arms. All the Patients will receive the study treatment drugs for 7 to 14 days. Use Day 28 of last patient as a cut-off day, Collect the follow up visit data on both Day 28 and Day 90 of other patients．
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: ulinastatinCohort 1- Ulinastatin 4.8 million units per day |
| Cohort 2 | Experimental | Drug: ulinastatinCohort 2- Ulinastatin 2.4 million units per day |
| Cohort 3 | Experimental | Drug: ulinastatinCohort 3- Ulinastatin 1.2 million units per day |
| control group | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have provided signed written informed consent form (ICF) from the patient or the patient's legal representative;
- Male or Female patients ≥18 years of age;
- ARDS defined with using 2012 Berlin Criteria;
- ARDS diagnosed ≤7 days, and patients should be mechanically ventilated(invasive and or noninvasive mechanical ventilation); 5)100mmhg < PaO2/FiO2 < 250mmhg with CPAP/PEEP≥5 cmH2O;
Key exclusion criteria (15 listed)
- Patient with known hypersensitivity to Ulinastatin/adjuvant or patient with allergic constitution;
- Patients with artificial organs replacement therapy for liver or kidney；
- Glasgow Coma Scale (GCS)≤8；
- Cardiogenic pulmonary edema , and the cardiogenic pulmonary edema is as the only or primary reason for respiratory failure;
- ARDS caused by burning, drowning, poisoning;
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 |
|---|---|---|
| ulinastatinAlso: UTI, urinary trypsin inhibitor, bikuninPatients will receive the study drugs for 7 to 14 days | Drug | Cohort 1, Cohort 2, Cohort 3 |
| placeboPatients will receive the placebo for 7 to 14 days | Drug | control group |
Primary outcome
The incidence of adverse events(AEs) which can not excluded relatedness with study Product
Time frame: Day 1 to Day 90
9 secondary outcomes
Changes of PaO2/FiO2 ratio
Time frame: Day 0 and Day 1 to within 24h after the last treatment
Days alive and off ventilator
Time frame: Day 1 to Day 28
Days in the ICU
Time frame: Day 1 to Day 14
Changes of pulmonary compliance
Time frame: Day 1 , Day 3 ,Day7 and within 24h after the last treatment
Rate of new organ failure
Time frame: Day 1 to Day 90
Changes of APACHEⅡ Score from baseline
Time frame: Day 3 ,Day7 and within 24h after the last treatment
Changes of Murray Lung Injury Score from baseline
Time frame: Day 3 ,Day7 and within 24h after the last treatment
Changes of Sequential Organ Failure Assessment (SOFA) score from baseline
Time frame: Day 3 ,Day7 and within 24h after the last treatment
All-cause mortality
Time frame: Day 28 , Day 90 and Day 1 to Day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
Yimin Li, Doctor principal investigator
First Affiliated Hospital of Guangzhou Medical University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ulinastatin in people with Acute Respiratory Distress Syndrome, run by Techpool Bio-Pharma Co., Ltd. at 11 sites 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 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adverse events(AEs) which can not excluded relatedness with study Product (time frame: Day 1 to Day 90). 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 20 Apr 2018.