Severe Hepatic ImpairmentPhase 1MCI-186-E05 HPNCT03664544
PK Study in Subjects With Severe Hepatic Impairment
A Phase 1 study testing MCI-186 in people with Severe Hepatic Impairment and Healthy, run by Shionogi at 3 sites in 3 countries.
Trial summary
This is an open-label, single-dose study in male and female subjects with severe hepatic impairment and in male and female subjects with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Hepatic Impairment, Healthy
- What is being tested?
- MCI-186
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 6 Nov 2018to 25 Mar 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects
- 1. Able to provide written informed consent to participate in this study after reading the participant information sheet and Informed Consent Form (ICF), and after having the opportunity to discuss the study with the Investigator or designee.
- 2. Male or female subjects age 18 to 75 years (inclusive) at signature of the ICF.
- 3. In the Investigator's opinion, subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the Protocol restrictions and requirements.
- 4. A body weight of ≥50 kg and a body mass index (Quetelet index) ranging from 18 to 37 kg/m2 (inclusive) at Screening and Day -1.
- 5. Female subjects who are:
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- postmenopausal for at least 1 year, confirmed by follicle-stimulating hormone assessment (>40 mIU/mL), or
- surgically sterilised (hysterectomy, bilateral oophorectomy or salpingectomy), or
- congenital sterility. Female subjects of child-bearing potential must practice effective contraception (see Protocol body) from the Screening Visit or at least 2 weeks before IMP administration, until 30 days after IMP dosing. Male subject must practice effective contraception from the time of IMP dosing until 90 days after IMP dosing. Adhering to strict abstinence is considered an accepted contraceptive method.
- Hepatic impaired subjects (in addition)
- 6. Diagnosis of cirrhosis due to parenchymal liver disease, which is documented in the medical history and physical examination and confirmed by at least one of the following: hepatic ultrasound, computed axial tomography scan, magnetic resonance imaging and/or liver biopsy. A Child-Pugh classification score of 10 to 14 obtained during the Screening period (i.e., within 21 days of IMP administration).
- 7. Chronic (>6 months) and stable hepatic impairment defined as no clinically significant change in disease status at least 14 days before Screening.
- 8. Acceptable clinical conditions in the opinion of the Investigator on the basis of a physical examination, medical history, 12-lead electrocardiogram (ECG), vital signs and clinical laboratory tests (biochemistry, haematology, coagulation and urinalysis) at Screening, Day -1 and pre-dose on Day 1. Subjects with stable mild chronic concurrent diseases, such as degenerative joint disease, controlled diabetes, hypertension or hyperlipidaemia, etc. may be included.
- Healthy subjects (in addition)
- 9. Subjects with normal hepatic function confirmed with tests within the normal reference range or results with minor deviations which are not considered by the Investigator to be clinically significant.
- 10. Good health and free from clinically significant illness or disease in the opinion of the Investigator on the basis of a physical examination, medical history, ECG, vital signs and clinical laboratory tests (biochemistry, haematology, coagulation and urinalysis) at Screening, Day -1 and pre-dose on Day 1.
Who cannot join
- All subjects
- 1. Presence or history of severe allergy to food, or any medical product or relevant excipient that is of clinical significance.
- 2. Subjects who have previously been administered MCI-186.
- 3. As a result of the medical screening process, the Investigator considers the subject not suitable for the study.
- 4. Clinically significant 12-lead ECG abnormalities, including but not limited to, corrected QT interval using Fridericia's formula (QTcF) of >450 ms (male subjects) or >470 ms (female subjects) at Screening, Day -1 or before dosing.
- 5. Any other history or condition (surgical or medical) of disease which will increase the risk to the subject, will affect the PK of the study drug, or will otherwise influence the assessments to be made in this study, in the opinion of the Investigator. Subjects who have undergone cholecystectomy may be included.
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- 6. History of drug abuse or tested positive for alcohol or drugs of abuse at Screening and Day -1, excluding drugs which may cause a positive drug or abuse test if medically indicated or prescribed.
- 7. Subjects who regularly, or on average, drink more than 35 units of alcohol per week (one unit is equivalent to 300 mL of beer, 25 mL of spirits or 150 mL of wine).
- 8. Presence of active infection requiring antibiotics.
- 9. Positive test for human immunodeficiency virus antigen/antibody at Screening.
- 10. Donation of one or more units of blood (450 mL) within 3 months prior to Screening, or plasma in the 7 days prior to Screening, or platelets in the 6 weeks prior to Screening, or the intention to donate blood within 3 months after the last Follow-up assessment.
- 11. Participation in another study within the last month (if single dose), or at least 4 months (if multiple dose), or within 10 times the half-life of the respective drug (whichever is longer) before Screening. For biologics, the minimum period is at least 6 months before Screening, the period of the pharmacodynamic effect, or 10 times the half life of the respective drug, whichever is longer.
- 12. Subject is currently taking non-permitted concomitant medication. The subjects with normal hepatic function are restricted from use of any concomitant medications (including paracetamol) unless discussed and agreed with the Sponsor. In subjects with hepatic impairment, the use of prescribed medications is permitted for hepatic or concomitant disease as described in the Protocol body.
- 13. Not willing to abstain from consumption of coffee, tea, cola, energy drinks or chocolates from admission to the unit (Day -1) to discharge from the unit (Day 3).
- 14. Uncontrolled, or untreated hypertension defined as a mean of three repeated measurements of systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg.
- 15. Subjects have estimated glomerular filtration rate <60 mL/min/1.73 m2 as determined by Modification of Diet in Renal Disease formula.
- 16. Any condition associated with dehydration.
- 17. Female subjects:
- who have a positive pregnancy test at Screening or on Day -1.
- who are pregnant, lactating or planning to become pregnant during the study.
- Hepatic impaired subjects (in addition)
- 18. Subjects with severe ascites or pleural effusion which will, in the opinion of the Investigator, adversely affect the subject's ability to participate in the study.
- 19. Subjects with severe encephalopathy (Grade III or IV).
- 20. Subjects with sclerosing cholangitis.
- 21. Serum albumin <2.0 g/dL.
- 22. Haemoglobin <10 g/dL.
- 23. Start of any new medication or any changes to a current dosage within 14 days before IMP administration.
- Healthy subjects (in addition)
- 24. History or presence of any parenchymal hepatic disease.
- 25. Positive test for hepatitis B surface antigen or hepatitis C virus antibody.
- 26. History of or active suicidal ideation, or suicide attempt as evidenced by positive response to either Question 4 (active suicidal ideation with some intent to act) or Question 5 (active suicidal ideation with specific plan and intent) on the Columbia-Suicide Severity Rating Scale (C-SSRS; Screening Version).
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MCI-186 in Subjects With Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
This is an open-label, single-dose study in male and female subjects with severe hepatic impairment and in male and female subjects with normal hepatic function.
- Conditions
- Severe Hepatic Impairment, Healthy
- Being tested
- MCI-186
- Keywords
- Severe Hepatic Impairment, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCI-186Drug
Also called Edaravone, Radicava, Radicut
30 mg MCI-186 will be administered intravenously over 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with severe hepatic impairment | Experimental | HP PK MCI-186 Receives: Drug: MCI-186 |
| Subjects with normal hepatic function | Experimental | NHV PK MCI-186 Receives: Drug: MCI-186 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Parameters of MCI-186: Peak Drug Concentration (Cmax)
Unchanged MCI-186
Measured: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Pharmacokinetic Parameters of MCI-186: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last)
Unchanged MCI-186
Measured: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Pharmacokinetic Parameters of MCI-186: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞)
Unchanged MCI-186
Measured: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Secondary outcomes (10)
Incidence of Adverse Events (AEs) and Serious Adverse Events
Number of adverse events
Measured: Day -1 to Day 7
Pharmacokinetic Parameters of MCI-186: Half-life (t½)
Unchanged MCI-186
Measured: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Pharmacokinetic Parameters of MCI-186: Time to Reach Peak Concentration (Tmax)
Unchanged MCI-186
Measured: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Pharmacokinetic Parameters of MCI-186: Terminal Elimination Rate Constant (λZ)
Unchanged MCI-186
Measured: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Pharmacokinetic Parameters of MCI-186: Total Clearance (CL)
Unchanged MCI-186
Measured: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Pharmacokinetic Parameters of MCI-186: Volume of Distribution at Steady State (Vss)
Unchanged MCI-186
Measured: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Pharmacokinetic Parameters of MCI-186: Volume of Distribution During the Terminal Phase (VZ)
Unchanged MCI-186
Measured: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Pharmacokinetic Parameters of MCI-186: Mean Residence Time (MRT)
Unchanged MCI-186
Measured: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Pharmacokinetic Parameters of MCI-186: Unbound Area Under the Concentration-time Curve From Time Zero to Infinity (AUCu0-∞)
Unchanged MCI-186
Measured: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Pharmacokinetic Parameters of MCI-186: Unbound Total Clearance (Clu)
Unchanged MCI-186
Measured: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start6 Nov 2018
- Primary completion25 Mar 2019
- Study completion25 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shionogi Clinical Trials Administrator Clinical Support Help Line, Study director, Shionogi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664544
- Sponsor's protocol ID
- MCI-186-E05
- Other IDs
- 2018-001163-23, 2018
- Acronym
- MCI-186-E05 HP
- Status last verified
- Jun 2026
- First submitted
- 27 Aug 2018
- Last updated
- 15 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Nakamaru Y, Kakubari M, Yoshida K, Akimoto M, Todorovic V, Greis T, Kondo K. Open-label, Single-dose Studies of the Pharmacokinetics of Edaravone in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects with Normal Hepatic Functioning. Clin Ther. 2020 Aug;42(8):1467-1482.e4. doi: 10.1016/j.clinthera.2020.06.016. Epub 2020 Aug 14.
PubMed 32800532
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MCI-186 in Subjects With Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT03664544
- Acronym / sponsor ID
- MCI-186-E05 HP / MCI-186-E05
- Conditions
- Severe Hepatic Impairment, Healthy
- Keywords
- Severe Hepatic Impairment, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- ShionogiIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 25 Mar 2019 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Posted 7 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single-dose study in male and female subjects with severe hepatic impairment and in male and female subjects with normal hepatic function.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with severe hepatic impairment | Experimental | Drug: MCI-186HP PK MCI-186 |
| Subjects with normal hepatic function | Experimental | Drug: MCI-186NHV PK MCI-186 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- All subjects
- 1. Able to provide written informed consent to participate in this study after reading the participant information sheet and Informed Consent Form (ICF), and after having the opportunity to discuss the study with the Investigator or designee.
- 2. Male or female subjects age 18 to 75 years (inclusive) at signature of the ICF.
- 3. In the Investigator's opinion, subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the Protocol restrictions and requirements.
- 4. A body weight of ≥50 kg and a body mass index (Quetelet index) ranging from 18 to 37 kg/m2 (inclusive) at Screening and Day -1.
Key exclusion criteria (31 listed)
- All subjects
- 1. Presence or history of severe allergy to food, or any medical product or relevant excipient that is of clinical significance.
- 2. Subjects who have previously been administered MCI-186.
- 3. As a result of the medical screening process, the Investigator considers the subject not suitable for the study.
- 4. Clinically significant 12-lead ECG abnormalities, including but not limited to, corrected QT interval using Fridericia's formula (QTcF) of >450 ms (male subjects) or >470 ms (female subjects) at Screening, Day -1 or before dosing.
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 |
|---|---|---|
| MCI-186Also: Edaravone, Radicava, Radicut30 mg MCI-186 will be administered intravenously over 60 minutes. | Drug | Subjects with normal hepatic function, Subjects with severe hepatic impairment |
Primary outcome
Pharmacokinetic Parameters of MCI-186: Peak Drug Concentration (Cmax)
Time frame: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Unchanged MCI-186
Pharmacokinetic Parameters of MCI-186: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last)
Time frame: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Unchanged MCI-186
Pharmacokinetic Parameters of MCI-186: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞)
Time frame: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Unchanged MCI-186
10 secondary outcomes
Incidence of Adverse Events (AEs) and Serious Adverse Events
Time frame: Day -1 to Day 7
Pharmacokinetic Parameters of MCI-186: Half-life (t½)
Time frame: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Pharmacokinetic Parameters of MCI-186: Time to Reach Peak Concentration (Tmax)
Time frame: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Pharmacokinetic Parameters of MCI-186: Terminal Elimination Rate Constant (λZ)
Time frame: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Pharmacokinetic Parameters of MCI-186: Total Clearance (CL)
Time frame: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Pharmacokinetic Parameters of MCI-186: Volume of Distribution at Steady State (Vss)
Time frame: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Pharmacokinetic Parameters of MCI-186: Volume of Distribution During the Terminal Phase (VZ)
Time frame: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Pharmacokinetic Parameters of MCI-186: Mean Residence Time (MRT)
Time frame: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Pharmacokinetic Parameters of MCI-186: Unbound Area Under the Concentration-time Curve From Time Zero to Infinity (AUCu0-∞)
Time frame: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Pharmacokinetic Parameters of MCI-186: Unbound Total Clearance (Clu)
Time frame: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32800532Nakamaru Y, Kakubari M, Yoshida K, Akimoto M, Todorovic V, Greis T, Kondo K. Open-label, Single-dose Studies of the Pharmacokinetics of Edaravone in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects with Normal Hepatic Functioning. Clin Ther. 2020 Aug;42(8):1467-1482.e4. doi: 10.1016/j.clinthera.2020.06.016. Epub 2020 Aug 14.
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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.
Shionogi Clinical Trials Administrator Clinical Support Help Line study director
Shionogi
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MCI-186 in people with Severe Hepatic Impairment and Healthy, run by Shionogi at 3 sites in 3 countries.
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 16 inclusion and 31 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: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia, Hungary, Slovakia. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pharmacokinetic Parameters of MCI-186: Peak Drug Concentration (Cmax) (time frame: Day 1 to 3 (Pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03664544, which also lists 1 linked publication.
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 15 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.