Intracerebral HemorrhagePhase 2GLICHNCT07613437
GLP-1 Receptor Agonist in Primary Intracerebral Hemorrhage: A Phase 2 Randomized Trial
A Phase 2 study testing Semaglutide, 0.5 mg/mL in people with Intracerebral Hemorrhage, run by Chinese University of Hong Kong at 3 sites in 2 countries.
Trial summary
Intracerebral hemorrhage (ICH) is a devastating form of acute stroke with poor clinical outcomes. Although ICH accounted only for 28.8% of incident strokes, it was responsible for nearly half of the long-term burden of stroke measured in disability-adjusted life years . Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Semaglutide, 0.5 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 15 Jun 2026to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 1. Primary spontaneous ICH with hematoma location in putamen (10-30mL) or thalamus (5-15mL) on admission CT imaging. Both locations are selected because they are strongly associated with hypertensive arteriopathy-related ICH and there is limited evidence supporting neurosurgical intervention compared with posterior fossa hemorrhages. The thalamic and putaminal volume cutoffs are based on a recent observational study showing that restricting enrolment to 5-15 mL (thalamus) and 10-30 mL (putamen) enriches for patients with substantial but potentially modifiable prognosis while avoiding extremes with ceiling or floor effects. For patients with hematoma involving both putamen and thalamus, a volume cutoff of 5-30mL will be used.
- 2. National Institutes of Health Stroke Scale (NIHSS) score ≥ 6 AND ≤ 25 at presentation
- 3. Glasgow Coma Scale (GCS) score ≥ 10
- 4. Last-known-well (LKW) to presentation time ≤ 24 hours
- 5. Pre-stroke modified Rankin Scale (mRS) ≤ 2
- 6. Patients deemed not suitable for acute neurosurgical intervention at the time of randomization
- 7. Informed consent obtained from patient (if mentally competent) or legal representative, as per national laws, regulations, and applicable ethics committee requirements
Who cannot join
- 1. Secondary ICH: ICH due to macrovascular abnormalities (e.g., arteriovenous malformation, aneurysm, arterial dissection, cavernous malformation), coagulopathy, anticoagulant use, antiplatelet overdose, or thrombocytopenia.
- 2. ICH involving locations other than putamen or thalamus (e.g., lobar, brainstem, cerebellar, isolated intraventricular hemorrhage). Extension of hematoma into other structures is allowed if the hematoma centroid is within the thalamus or putamen, and the hematoma volume does not exist the respective thresholds as stated in Inclusion Criterion 1.
- 3. ICH with planned neurosurgical procedure prior to randomization, including hematoma evacuation, external ventricular drainage and decompressive craniectomy.
- 4. Estimated or known body mass index (BMI) < 18 kg/m².
- 5. Pregnancy, lactation, or positive urine or serum beta human chorionic gonadotropin (β-hCG) test. β-hCG testing should be guided by clinical need.
- 6. Creatinine clearance < 30 mL/min (estimated by Cockcroft-Gault equation or measured)
Show all 12Show fewer
- 7. Severe or fatal comorbid illness with life expectancy < 3 years (e.g., terminal malignancy, advanced organ failure)
- 8. Participation in another clinical trial investigating a drug, medical device, or medical procedure within 30 days preceding trial inclusion.
- 9. Known history of allergy or hypersensitivity to GLP-1RA.
- 10. Family or personal history of multiple endocrine neoplasia (MEN), medullary thyroid carcinoma, or pancreatic carcinoma
- 11. Active sepsis at time of randomization, defined as a body temperature of ≥ 38.5C, or suspected or documented infection and acute organ dysfunction, operationalized as an increase in SOFA score ≥ 2 points from baseline (baseline assumed 0 if no pre-existing organ dysfunction)
- 12. Contraindications to proposed imaging studies (e.g., pacemaker incompatibility with MRI where applicable)
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
China2 sites
The First Affiliated Hospital of University of Science and Technology China
Hefei, Anhui
Wei HU, MD, andinghu@ustc.edu.cn
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Xinshi WANG, MD, wangxinshi@wmu.edu.cn
Hong Kong1 site
Chinese University of Hong Kong
Hong Kong
Bonaventure Yiu Ming IP, MBChB, PhD, 852-28902002, bonaventureip@cuhk.edu.hk
About this study
Intracerebral hemorrhage (ICH) is a devastating form of acute stroke with poor clinical outcomes. Although ICH accounted only for 28.8% of incident strokes, it was responsible for nearly half of the long-term burden of stroke measured in disability-adjusted life years . In contrast to the improving outcomes seen in ischemic stroke with advances in reperfusion therapy, outcomes of patients with ICH have shown little progress over the past two decades. Current standard care focuses primarily on blood pressure control and supportive management, yet rate of functional independence remained modest. Randomized evidence suggested that fewer than half of the ICH patients achieved independent activities of daily living even with intensive blood pressure lowering.
A cascade of pathophysiological events is thought to determine the prognosis of ICH. First, the mass effect of the hematoma and its expansion with uncontrolled blood pressure cause primary neuronal injury. Second, neuroinflammation involving blood-brain barrier (BBB) dysfunction, activated microglia and astrocytes, together with neutrophil infiltration in response to extravascular blood, propagates neuronal injury, leading to perihematomal edema. Third, the direct neurotoxicity of blood breakdown products and oxidative stress may further amplify neuroinflammation. Mitigating hematoma expansion through intensive blood pressure control therefore only addresses one of these three pathophysiological processes, and is constrained by a short treatment window, mostly within 6 hours. Therapeutic strategies targeting secondary neuroinflammation should therefore be actively pursued. In addition, multimodal studies incorporating longitudinal imaging and omics markers are needed to elucidate the key pathways mediating neuroinflammation following ICH.
Read more
Recent preclinical evidence suggests that glucagon-like peptide-1 receptor agonists (GLP-1RA) may offer neuroprotective benefits in ICH. In animal models of ICH, intracerebroventricular liraglutide suppressed neuroinflammation, prevented brain edema, and reduced neurologic deficits. Previous work from our group has also shown that, across several animal models, GLP-1RA attenuates BBB dysfunction and suppresses neuroinflammatory signaling via microglial modulation. Importantly, a recent translational clinical trial by our team has also provided preliminary evidence that GLP-1RA exerts neuroprotective effects in patients with large vessel occlusion strokes. We therefore hypothesize that compared to standard therapy, administration of GLP-1RA in patients with primary ICH may limit perihaematomal edema, reduce secondary brain injury, and improve neurological outcomes.
In this phase 2, randomized, open-label pilot study with blinded endpoint assessment, we aim to determine the safety and signals for efficacy of GLP-1RA in patients with primary ICH.
Read the detailed description
GLP-1RA in Primary Intracerebral Hemorrhage (GLICH) trial is an investigator-initiated, phase 2, multicenter, randomized, open-label trial with blinded endpoint assessment, conducted across centers in Hong Kong Special Administrative Region (HKSAR), Wenzhou and Hefei, China. We aim to recruit 200 patients with primary ICH in the putamen (10-30mL) or thalamus (5-15mL) who present within 24 hours of last-known-well and meet all eligibility criteria. Participants will be randomized in a 1:1 ratio to receive additional semaglutide or just standard therapy after a written informed consent. Patients in the semaglutide group will receive subcutaneous injections of semaglutide on baseline (D0), Day 7 (D7), Day 14 (D14) and Day 21 (D21) after enrollment.
Serial imaging with non-contrast computed tomography (CT) will be performed at baseline, 3+/-1 days, and 7+/-1 days post-enrollment to assess hematoma volume, hematoma expansion, and perihematomal edema (PHE). Brain magnetic resonance imaging (MRI) will be arranged on Day 5-9 (D30) post-ICH to assess the degree of neuronal injury. Blood sampling for omics analysis will be collected at baseline, D3, D7, D14 and D30. Other investigations will be arranged according to clinical requirement. Clinical assessments including National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), Montreal Cognitive Assessment (MoCA) and Mini Mental State Examination (MMSE) will be obtained on D0, Day 90 (D90) and Day 180 (D180). Recruitment targets are 100 patients from Wenzhou, 75 from Hefei and 25 patients from HKSAR according to catchment area size.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Semaglutide, 0.5 mg/mL
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide, 0.5 mg/mLDrug
0.5mg weekly via subcutaneous injection, a total of 4 injections are given, on Day 0 (D0 day of enrollment, within 24 hours of ICH onset), Day 7 (D7), Day 14 (D14) and Day 21 (D21) after enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide Group | Active comparator | Patients randomized into the semaglutide group will receive subcutaneous injections of semaglutide on baseline (D0), Day 7 (D7), Day 14 (D14) and Day 21 (D21) after enrollment. Receives: Drug: Semaglutide, 0.5 mg/mL |
| Standard of care | No intervention | Standard medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edema extension distance on Day 7
The perpendicular distance from the hematoma margin to the outermost extent of perihematomal edema on CT imaging.
Measured: Day 7
Secondary outcomes (9)
Proportion of patients with excellent functional outcome (mRS 0-1)
Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Measured: Day 90±14 and Day 180±14
Proportion of patients with functional independence (mRS 0-2)
Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Measured: Day 90±14 and Day 180±14
Proportion of patients with ambulatory independence (mRS 0-3)
Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Measured: Day 90±14 and Day 180±14
Ordinal shift of modified Rankin Scale
Modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Measured: Day 90±14 and Day 180±14
6. Neurological function of participants assessed by National Institute of Health Stroke Scale
Zero indicates no stroke symptoms, 1-4 , 5-15, 16-20, 21-42 indicate minor, moderate, moderate to severe, and severe stroke, respectively.
Measured: Day 3, Day 7, Day 14, Day 30, Day 90 and Day 180
Hematoma expansion
Absolute increase in hematoma volume by ≥ 6mL OR relative increase in hematoma volume by ≥ 33%
Measured: Day 3, Day 7
Perihematomal edema volume
Volume of edema surrounding the intracerebral hematoma
Measured: Day 3, Day 7
Edema extension distance on Day 3
The perpendicular distance from the hematoma margin to the outermost extent of perihematomal edema on CT imaging.
Measured: Day 3
Need for acute neurosurgical intervention
Any neurosurgical intervention performed as a result of neurological or radiological deterioration.
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start15 Jun 2026 (estimated)
- Primary completion14 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 200 participants will be randomized in a 1:1 ratio to receive additional semaglutide or just standard therapy after a written informed consent.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of University of Science and Technology of China, First Affiliated Hospital of Wenzhou Medical University
- Responsible party
- Principal investigator, Dr. IP Yiu Ming Bonaventure, Chinese University of Hong Kong
- Investigators
- Bonaventure Yiu Ming IP, MB ChB,PhD, Principal investigator, Chinese University of Hong KongWei HU, MD, Principal investigator, The First Affiliated Hospital of University of Science and Technology of ChinaXinshi WANG, MD, Principal investigator, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613437
- Sponsor's protocol ID
- CREC 2026.169
- Acronym
- GLICH
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLP-1 Receptor Agonist in Primary Intracerebral Hemorrhage: A Phase 2 Randomized Trial
- ClinicalTrials.gov ID
- NCT07613437
- Acronym / sponsor ID
- GLICH / CREC 2026.169
- Conditions
- Intracerebral Hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of University of Science and Technology of China, First Affiliated Hospital of Wenzhou Medical University
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 14 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 May 2026 (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.
Intracerebral hemorrhage (ICH) is a devastating form of acute stroke with poor clinical outcomes. Although ICH accounted only for 28.8% of incident strokes, it was responsible for nearly half of the long-term burden of stroke measured in disability-adjusted life years . In contrast to the improving outcomes seen in ischemic stroke with advances in reperfusion therapy, outcomes of patients with ICH have shown little progress over the past two decades. Current standard care focuses primarily on blood pressure control and supportive management, yet rate of functional independence remained modest. Randomized evidence suggested that fewer than half of the ICH patients achieved independent activities of daily living even with intensive blood pressure lowering.
A cascade of pathophysiological events is thought to determine the prognosis of ICH. First, the mass effect of the hematoma and its expansion with uncontrolled blood pressure cause primary neuronal injury. Second, neuroinflammation involving blood-brain barrier (BBB) dysfunction, activated microglia and astrocytes, together with neutrophil infiltration in response to extravascular blood, propagates neuronal injury, leading to perihematomal edema. Third, the direct neurotoxicity of blood breakdown products and oxidative stress may further amplify neuroinflammation. Mitigating hematoma expansion through intensive blood pressure control therefore only addresses one of these three pathophysiological processes, and is constrained by a short treatment window, mostly within 6 hours. Therapeutic strategies targeting secondary neuroinflammation should therefore be actively pursued. In addition, multimodal studies incorporating longitudinal imaging and omics markers are needed to elucidate the key pathways mediating neuroinflammation following ICH.
Recent preclinical evidence suggests that glucagon-like peptide-1 receptor agonists (GLP-1RA) may offer neuroprotective benefits in ICH. In animal models of ICH, intracerebroventricular liraglutide suppressed neuroinflammation, prevented brain edema, and reduced neurologic deficits. Previous work from our group has also shown that, across several animal models, GLP-1RA attenuates BBB dysfunction and suppresses neuroinflammatory signaling via microglial modulation. Importantly, a recent translational clinical trial by our team has also provided preliminary evidence that GLP-1RA exerts neuroprotective effects in patients with large vessel occlusion strokes. We therefore hypothesize that compared to standard therapy, administration of GLP-1RA in patients with primary ICH may limit perihaematomal edema, reduce secondary brain injury, and improve neurological outcomes.
In this phase 2, randomized, open-label pilot study with blinded endpoint assessment, we aim to determine the safety and signals for efficacy of GLP-1RA in patients with primary ICH.
Detailed description
GLP-1RA in Primary Intracerebral Hemorrhage (GLICH) trial is an investigator-initiated, phase 2, multicenter, randomized, open-label trial with blinded endpoint assessment, conducted across centers in Hong Kong Special Administrative Region (HKSAR), Wenzhou and Hefei, China. We aim to recruit 200 patients with primary ICH in the putamen (10-30mL) or thalamus (5-15mL) who present within 24 hours of last-known-well and meet all eligibility criteria. Participants will be randomized in a 1:1 ratio to receive additional semaglutide or just standard therapy after a written informed consent. Patients in the semaglutide group will receive subcutaneous injections of semaglutide on baseline (D0), Day 7 (D7), Day 14 (D14) and Day 21 (D21) after enrollment.
Serial imaging with non-contrast computed tomography (CT) will be performed at baseline, 3+/-1 days, and 7+/-1 days post-enrollment to assess hematoma volume, hematoma expansion, and perihematomal edema (PHE). Brain magnetic resonance imaging (MRI) will be arranged on Day 5-9 (D30) post-ICH to assess the degree of neuronal injury. Blood sampling for omics analysis will be collected at baseline, D3, D7, D14 and D30. Other investigations will be arranged according to clinical requirement. Clinical assessments including National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), Montreal Cognitive Assessment (MoCA) and Mini Mental State Examination (MMSE) will be obtained on D0, Day 90 (D90) and Day 180 (D180). Recruitment targets are 100 patients from Wenzhou, 75 from Hefei and 25 patients from HKSAR according to catchment area size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 200 participants will be randomized in a 1:1 ratio to receive additional semaglutide or just standard therapy after a written informed consent.
| Arm | Type | Receives |
|---|---|---|
| Semaglutide Group | Active comparator | Drug: Semaglutide, 0.5 mg/mLPatients randomized into the semaglutide group will receive subcutaneous injections of semaglutide on baseline (D0), Day 7 (D7), Day 14 (D14) and Day 21 (D21) after enrollment. |
| Standard of care | No intervention | –Standard medical therapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Primary spontaneous ICH with hematoma location in putamen (10-30mL) or thalamus (5-15mL) on admission CT imaging. Both locations are selected because they are strongly associated with hypertensive arteriopathy-related ICH and there is limited evidence supporting neurosurgical intervention compared with posterior fossa hemorrhages. The thalamic and putaminal volume cutoffs are based on a recent observational study showing that restricting enrolment to 5-15 mL (thalamus) and 10-30 mL (putamen) enriches for patients with substantial but potentially modifiable prognosis while avoiding extremes with ceiling or floor effects. For patients with hematoma involving both putamen and thalamus, a volume cutoff of 5-30mL will be used.
- 2. National Institutes of Health Stroke Scale (NIHSS) score ≥ 6 AND ≤ 25 at presentation
- 3. Glasgow Coma Scale (GCS) score ≥ 10
- 4. Last-known-well (LKW) to presentation time ≤ 24 hours
- 5. Pre-stroke modified Rankin Scale (mRS) ≤ 2
Key exclusion criteria (12 listed)
- 1. Secondary ICH: ICH due to macrovascular abnormalities (e.g., arteriovenous malformation, aneurysm, arterial dissection, cavernous malformation), coagulopathy, anticoagulant use, antiplatelet overdose, or thrombocytopenia.
- 2. ICH involving locations other than putamen or thalamus (e.g., lobar, brainstem, cerebellar, isolated intraventricular hemorrhage). Extension of hematoma into other structures is allowed if the hematoma centroid is within the thalamus or putamen, and the hematoma volume does not exist the respective thresholds as stated in Inclusion Criterion 1.
- 3. ICH with planned neurosurgical procedure prior to randomization, including hematoma evacuation, external ventricular drainage and decompressive craniectomy.
- 4. Estimated or known body mass index (BMI) < 18 kg/m².
- 5. Pregnancy, lactation, or positive urine or serum beta human chorionic gonadotropin (β-hCG) test. β-hCG testing should be guided by clinical need.
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 |
|---|---|---|
| Semaglutide, 0.5 mg/mL0.5mg weekly via subcutaneous injection, a total of 4 injections are given, on Day 0 (D0 day of enrollment, within 24 hours of ICH onset), Day 7 (D7), Day 14 (D14) and Day 21 (D21) after enrollment. | Drug | Semaglutide Group |
Primary outcome
Edema extension distance on Day 7
Time frame: Day 7
The perpendicular distance from the hematoma margin to the outermost extent of perihematomal edema on CT imaging.
9 secondary outcomes
Proportion of patients with excellent functional outcome (mRS 0-1)
Time frame: Day 90±14 and Day 180±14
Proportion of patients with functional independence (mRS 0-2)
Time frame: Day 90±14 and Day 180±14
Proportion of patients with ambulatory independence (mRS 0-3)
Time frame: Day 90±14 and Day 180±14
Ordinal shift of modified Rankin Scale
Time frame: Day 90±14 and Day 180±14
6. Neurological function of participants assessed by National Institute of Health Stroke Scale
Time frame: Day 3, Day 7, Day 14, Day 30, Day 90 and Day 180
Hematoma expansion
Time frame: Day 3, Day 7
Perihematomal edema volume
Time frame: Day 3, Day 7
Edema extension distance on Day 3
Time frame: Day 3
Need for acute neurosurgical intervention
Time frame: Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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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.
Bonaventure Yiu Ming IP, MB ChB,PhD principal investigator
Chinese University of Hong Kong
Wei HU, MD principal investigator
The First Affiliated Hospital of University of Science and Technology of China
Xinshi WANG, MD principal investigator
First Affiliated Hospital of Wenzhou Medical University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Semaglutide, 0.5 mg/mL in people with Intracerebral Hemorrhage, run by Chinese University of Hong Kong at 3 sites in 2 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 7 inclusion and 12 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: opening soon, as of the sponsor's last update on 29 May 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 China, Hong Kong. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bonaventure Yiu Ming IP, MB ChB,PhD (852-28902002, bonaventureip@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edema extension distance on Day 7 (time frame: Day 7). 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 29 May 2026.