Spontaneous Subarachnoid HemorrhagePhase 2BLISSNCT06439615
Baricitinib for the Lung Injury Following Spontaneous SAH
A Phase 2 study testing Baricitinib 4 MG and Standard treatment in people with Spontaneous Subarachnoid Hemorrhage, run by Tang-Du Hospital.
Trial summary
The present study is a randomized, parallel control, and double-blind trial designed to assess the efficacy of baricitinib in reducing the occurrence of pulmonary complications in patients with spontaneous subarachnoid hemorrhage (SAH). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spontaneous Subarachnoid Hemorrhage
- What is being tested?
- Baricitinib 4 MG and Standard treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 30 Jun 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤80 years old;
- Diagnosed with spontaneous subarachnoid hemorrhage through imaging or lumbar puncture;
- Hunt-Hess score of Ⅲ-Ⅳ;
- Acute onset, admitted to the hospital within 24 hours of onset
Who cannot join
- Presence of lung diseases before initiation of study treatment such as chronic obstructive emphysema, bronchiectasis, lung cancer, tuberculosis, or a history of lung surgery;
- Presence of autoimmune diseases, immune system dysfunction, or blood system dysfunction (absolute lymphocyte count (ALC) less than 0.5×109 cells/L, absolute neutrophil count (ANC) less than 1×109 cells/L, or hemoglobin value less than 8 g/dL) before the onset of the disease;
- Secondary SAH (such as traumatic SAH), or combined craniocerebral trauma, intraparenchymal hemorrhage, or peripheral organ trauma;
- Evidence of fever or infection already present at the time of admission;
- History of previous craniocerebral surgery, previous cerebral hemorrhage, craniocerebral injury, cerebral infarction, intracranial tumor, or presence of neurological dysfunction before the onset of the disease;
- Presence of contraindications for baricitinib treatment, including severe liver damage, renal dysfunction (creatinine clearance rate <30ml/min), hypercholesterolemia, or known drug allergies;
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- Taking JAK inhibitors or other immunosuppressive drugs before the onset of the disease;
- Expected survival time less than 2 weeks;
- Females who are pregnant or breastfeeding;
- Currently participating in other interventional clinical studies;
- Patients who refuse to sign the consent form or refuse to accept follow-up.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Treatment Effect of Baricitinib for the Secondary Pulmonary Complications Following Spontaneous Subarachnoid Hemorrhage
The present study is a randomized, parallel control, and double-blind trial designed to assess the efficacy of baricitinib in reducing the occurrence of pulmonary complications in patients with spontaneous subarachnoid hemorrhage (SAH). The research protocol incorporates an adaptive design, allowing for modifications to key elements such as the sample size enrolled during interim analysis.
Read the detailed description
Subarachnoid hemorrhage (SAH) is an acute cerebrovascular disorder resulting from the rupture of intracranial vessels, primarily caused by factors such as the rupture of intracranial aneurysms (accounting for approximately 75%-80% of SAH cases), arteriovenous malformations, and abnormal vasculature.
Pulmonary complications, including pneumonia and acute respiratory distress syndrome (ARDS), frequently manifest in a significant number of subarachnoid hemorrhage (SAH) patients, significantly impacting their prognosis. The pathogenesis of these complications can be partially attributed to an exaggerated inflammatory response during the acute phase following SAH. The incidence of cerebrovascular spasm and mortality rates significantly increase in SAH patients with pulmonary complications, thereby resulting in a poorer long-term prognosis. However, the current strategy for preventing or managing pulmonary complications after SAH is not sufficiently effective.
The JAK-STAT signaling pathway, a pivotal stress-induced inflammatory cascade triggered subsequent to SAH, is characterized by its rapid response to external stimuli. Baricitinib, a JAK inhibitor developed by Eli Lilly Company, exerts significant anti-inflammatory effects in diverse pathological processes and finds extensive application in patients with rheumatoid arthritis, COVID-19, and alopecia areata. However, it remains uncertain whether early administration of baricitinib can mitigate the incidence of secondary pulmonary complications and enhance the prognosis of SAH by suppressing the exaggerated inflammatory response during the acute phase following SAH.
The current multicenter clinical trial is designed as a randomized, parallel control, and double-blind study to assess the efficacy of baricitinib in reducing pulmonary complications among patients with SAH. SAH Patients admitted to participating clinical centers with a Hunt-Hess score of Ⅲ-Ⅳ will undergo continuous screening based on predefined selection criteria. The enrolled subjects will be randomly allocated into an experimental group and a control group, receiving either Baricitinib (4mg/day for 3 days) in addition to conventional treatment or placebo in addition to conventional treatment, respectively. The primary outcome is the incidence of pneumonia within 14 days after SAH. While the secondary outcome including the incidence of ARDS and other pulmonary complications within 14 days, the incidence of serious adverse events within 14 days, the proportion of patients requiring assisted ventilation measures within 14 days, the mortality rate within 14/30/90 days, as well as the neurological outcome at 30/90 days.
- Conditions
- Spontaneous Subarachnoid Hemorrhage
- Being tested
- Baricitinib 4 MG, Standard treatment
- Keywords
- Spontaneous subarachnoid hemorrhage, Baricitinib, Inflammation, Complications, Acute respiratory distress syndrome, Pneumonia, Outcome
- Medical subject headings
- Subarachnoid Hemorrhage, Inflammation, Respiratory Distress Syndrome, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baricitinib 4 MGDrug
Also called JAK Inhibitor
Baricitinib will be administered orally (or crushed for nasogastric tube delivery) at a daily dosage of 4mg for three consecutive days following SAH.
Standard treatmentOther
Participants will receive standard treatment and care according to the current management guidelines for subarachnoid hemorrhage.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Participants will receive standard treatment and care according to the current management guidelines for SAH. Receives: Other: Standard treatment |
| Baricitinib group | Experimental | In addition to receiving standard treatment and care, baricitinib will be administrated orally (or crushed for nasogastric tube delivery) at a daily dosage of 4mg for three consecutive days following SAH. Receives: Drug: Baricitinib 4 MG; Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of pneumonia
Proportion of patients who occur pneumonia within 14 days
Measured: up to 14 days
Secondary outcomes (8)
The incidence of ARDS
The incidence of ARDS within 14 days following SAH.
Measured: up to 14 days
The incidence of other pulmonary complications
The incidence of additional pulmonary complications, such as pulmonary edema, pulmonary embolism, and pleural effusion among patients within 14 days following SAH.
Measured: up to 14 days
The incidence of assisted ventilation measures
The proportion of patients requiring assisted ventilation measures within 14 days following SAH.
Measured: up to 14 days
The incidence of Systemic Inflammatory Response Syndrome(SIRS)
The incidence of SIRS within 14 days following SAH.
Measured: up to 14 days
Mortality rate
The mortality rate within 14 days / 30 days / 90 days.
Measured: up to 90 days
The incidence of serious adverse events (SAE)
The incidence of SAE within 14 days following SAH.
Measured: up to 14 days
The neurological functional outcome
The neurological functional scores evaluated by Modified Rankin Scale and Glasgow Outcome Scale at 30 days and 90 days after SAH.
Measured: up to 90 days
The cognitive impairment after SAH
The Mini-Mental Status Exam (MMSE) scores at 90 days after SAH.
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Spontaneous Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Qu, PhD MD, Principal investigator, Department of Neurosurgery, Tangdu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439615
- Sponsor's protocol ID
- BAR-SAH
- Acronym
- BLISS
- Status last verified
- May 2024
- First submitted
- 28 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Robba C, Busl KM, Claassen J, Diringer MN, Helbok R, Park S, Rabinstein A, Treggiari M, Vergouwen MDI, Citerio G. Contemporary management of aneurysmal subarachnoid haemorrhage. An update for the intensivist. Intensive Care Med. 2024 May;50(5):646-664. doi: 10.1007/s00134-024-07387-7. Epub 2024 Apr 10.
PubMed 38598130Chai CZ, Ho UC, Kuo LT. Systemic Inflammation after Aneurysmal Subarachnoid Hemorrhage. Int J Mol Sci. 2023 Jun 30;24(13):10943. doi: 10.3390/ijms241310943.
PubMed 37446118Kahn JM, Caldwell EC, Deem S, Newell DW, Heckbert SR, Rubenfeld GD. Acute lung injury in patients with subarachnoid hemorrhage: incidence, risk factors, and outcome. Crit Care Med. 2006 Jan;34(1):196-202. doi: 10.1097/01.ccm.0000194540.44020.8e.
PubMed 16374174Macmillan CS, Grant IS, Andrews PJ. Pulmonary and cardiac sequelae of subarachnoid haemorrhage: time for active management? Intensive Care Med. 2002 Aug;28(8):1012-23. doi: 10.1007/s00134-002-1382-7. Epub 2002 Jul 6.
PubMed 12185419RECOVERY Collaborative Group. Baricitinib in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial and updated meta-analysis. Lancet. 2022 Jul 30;400(10349):359-368. doi: 10.1016/S0140-6736(22)01109-6.
PubMed 35908569Taylor PC, Laedermann C, Alten R, Feist E, Choy E, Haladyj E, De La Torre I, Richette P, Finckh A, Tanaka Y. A JAK Inhibitor for Treatment of Rheumatoid Arthritis: The Baricitinib Experience. J Clin Med. 2023 Jul 6;12(13):4527. doi: 10.3390/jcm12134527.
PubMed 37445562Ely EW, Ramanan AV, Kartman CE, de Bono S, Liao R, Piruzeli MLB, Goldman JD, Saraiva JFK, Chakladar S, Marconi VC; COV-BARRIER Study Group. Efficacy and safety of baricitinib plus standard of care for the treatment of critically ill hospitalised adults with COVID-19 on invasive mechanical ventilation or extracorporeal membrane oxygenation: an exploratory, randomised, placebo-controlled trial. Lancet Respir Med. 2022 Apr;10(4):327-336. doi: 10.1016/S2213-2600(22)00006-6. Epub 2022 Feb 3.
PubMed 35123660Taylor PC, Keystone EC, van der Heijde D, Weinblatt ME, Del Carmen Morales L, Reyes Gonzaga J, Yakushin S, Ishii T, Emoto K, Beattie S, Arora V, Gaich C, Rooney T, Schlichting D, Macias WL, de Bono S, Tanaka Y. Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis. N Engl J Med. 2017 Feb 16;376(7):652-662. doi: 10.1056/NEJMoa1608345.
PubMed 28199814
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment Effect of Baricitinib for the Secondary Pulmonary Complications Following Spontaneous Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT06439615
- Acronym / sponsor ID
- BLISS / BAR-SAH
- Conditions
- Spontaneous Subarachnoid Hemorrhage
- Keywords
- Spontaneous subarachnoid hemorrhage, Baricitinib, Inflammation, Complications, Acute respiratory distress syndrome, Pneumonia, Outcome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Jun 2024 (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.
The present study is a randomized, parallel control, and double-blind trial designed to assess the efficacy of baricitinib in reducing the occurrence of pulmonary complications in patients with spontaneous subarachnoid hemorrhage (SAH). The research protocol incorporates an adaptive design, allowing for modifications to key elements such as the sample size enrolled during interim analysis.
Detailed description
Subarachnoid hemorrhage (SAH) is an acute cerebrovascular disorder resulting from the rupture of intracranial vessels, primarily caused by factors such as the rupture of intracranial aneurysms (accounting for approximately 75%-80% of SAH cases), arteriovenous malformations, and abnormal vasculature.
Pulmonary complications, including pneumonia and acute respiratory distress syndrome (ARDS), frequently manifest in a significant number of subarachnoid hemorrhage (SAH) patients, significantly impacting their prognosis. The pathogenesis of these complications can be partially attributed to an exaggerated inflammatory response during the acute phase following SAH. The incidence of cerebrovascular spasm and mortality rates significantly increase in SAH patients with pulmonary complications, thereby resulting in a poorer long-term prognosis. However, the current strategy for preventing or managing pulmonary complications after SAH is not sufficiently effective.
The JAK-STAT signaling pathway, a pivotal stress-induced inflammatory cascade triggered subsequent to SAH, is characterized by its rapid response to external stimuli. Baricitinib, a JAK inhibitor developed by Eli Lilly Company, exerts significant anti-inflammatory effects in diverse pathological processes and finds extensive application in patients with rheumatoid arthritis, COVID-19, and alopecia areata. However, it remains uncertain whether early administration of baricitinib can mitigate the incidence of secondary pulmonary complications and enhance the prognosis of SAH by suppressing the exaggerated inflammatory response during the acute phase following SAH.
The current multicenter clinical trial is designed as a randomized, parallel control, and double-blind study to assess the efficacy of baricitinib in reducing pulmonary complications among patients with SAH. SAH Patients admitted to participating clinical centers with a Hunt-Hess score of Ⅲ-Ⅳ will undergo continuous screening based on predefined selection criteria. The enrolled subjects will be randomly allocated into an experimental group and a control group, receiving either Baricitinib (4mg/day for 3 days) in addition to conventional treatment or placebo in addition to conventional treatment, respectively. The primary outcome is the incidence of pneumonia within 14 days after SAH. While the secondary outcome including the incidence of ARDS and other pulmonary complications within 14 days, the incidence of serious adverse events within 14 days, the proportion of patients requiring assisted ventilation measures within 14 days, the mortality rate within 14/30/90 days, as well as the neurological outcome at 30/90 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Other: Standard treatmentParticipants will receive standard treatment and care according to the current management guidelines for SAH. |
| Baricitinib group | Experimental | Drug: Baricitinib 4 MG, Other: Standard treatmentIn addition to receiving standard treatment and care, baricitinib will be administrated orally (or crushed for nasogastric tube delivery) at a daily dosage of 4mg for three consecutive days following SAH. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 and ≤80 years old;
- Diagnosed with spontaneous subarachnoid hemorrhage through imaging or lumbar puncture;
- Hunt-Hess score of Ⅲ-Ⅳ;
- Acute onset, admitted to the hospital within 24 hours of onset
Key exclusion criteria (11 listed)
- Presence of lung diseases before initiation of study treatment such as chronic obstructive emphysema, bronchiectasis, lung cancer, tuberculosis, or a history of lung surgery;
- Presence of autoimmune diseases, immune system dysfunction, or blood system dysfunction (absolute lymphocyte count (ALC) less than 0.5×109 cells/L, absolute neutrophil count (ANC) less than 1×109 cells/L, or hemoglobin value less than 8 g/dL) before the onset of the disease;
- Secondary SAH (such as traumatic SAH), or combined craniocerebral trauma, intraparenchymal hemorrhage, or peripheral organ trauma;
- Evidence of fever or infection already present at the time of admission;
- History of previous craniocerebral surgery, previous cerebral hemorrhage, craniocerebral injury, cerebral infarction, intracranial tumor, or presence of neurological dysfunction before the onset of the disease;
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 |
|---|---|---|
| Baricitinib 4 MGAlso: JAK InhibitorBaricitinib will be administered orally (or crushed for nasogastric tube delivery) at a daily dosage of 4mg for three consecutive days following SAH. | Drug | Baricitinib group |
| Standard treatmentParticipants will receive standard treatment and care according to the current management guidelines for subarachnoid hemorrhage. | Other | Baricitinib group, Control group |
Primary outcome
The incidence of pneumonia
Time frame: up to 14 days
Proportion of patients who occur pneumonia within 14 days
8 secondary outcomes
The incidence of ARDS
Time frame: up to 14 days
The incidence of other pulmonary complications
Time frame: up to 14 days
The incidence of assisted ventilation measures
Time frame: up to 14 days
The incidence of Systemic Inflammatory Response Syndrome(SIRS)
Time frame: up to 14 days
Mortality rate
Time frame: up to 90 days
The incidence of serious adverse events (SAE)
Time frame: up to 14 days
The neurological functional outcome
Time frame: up to 90 days
The cognitive impairment after SAH
Time frame: up to 90 days
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 3 Jun 2024.
- Background: PubMed 38598130Robba C, Busl KM, Claassen J, Diringer MN, Helbok R, Park S, Rabinstein A, Treggiari M, Vergouwen MDI, Citerio G. Contemporary management of aneurysmal subarachnoid haemorrhage. An update for the intensivist. Intensive Care Med. 2024 May;50(5):646-664. doi: 10.1007/s00134-024-07387-7. Epub 2024 Apr 10.
- Background: PubMed 37446118Chai CZ, Ho UC, Kuo LT. Systemic Inflammation after Aneurysmal Subarachnoid Hemorrhage. Int J Mol Sci. 2023 Jun 30;24(13):10943. doi: 10.3390/ijms241310943.
- Background: PubMed 16374174Kahn JM, Caldwell EC, Deem S, Newell DW, Heckbert SR, Rubenfeld GD. Acute lung injury in patients with subarachnoid hemorrhage: incidence, risk factors, and outcome. Crit Care Med. 2006 Jan;34(1):196-202. doi: 10.1097/01.ccm.0000194540.44020.8e.
- Background: PubMed 12185419Macmillan CS, Grant IS, Andrews PJ. Pulmonary and cardiac sequelae of subarachnoid haemorrhage: time for active management? Intensive Care Med. 2002 Aug;28(8):1012-23. doi: 10.1007/s00134-002-1382-7. Epub 2002 Jul 6.
- Background: PubMed 35908569RECOVERY Collaborative Group. Baricitinib in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial and updated meta-analysis. Lancet. 2022 Jul 30;400(10349):359-368. doi: 10.1016/S0140-6736(22)01109-6.
- Background: PubMed 37445562Taylor PC, Laedermann C, Alten R, Feist E, Choy E, Haladyj E, De La Torre I, Richette P, Finckh A, Tanaka Y. A JAK Inhibitor for Treatment of Rheumatoid Arthritis: The Baricitinib Experience. J Clin Med. 2023 Jul 6;12(13):4527. doi: 10.3390/jcm12134527.
- Background: PubMed 35123660Ely EW, Ramanan AV, Kartman CE, de Bono S, Liao R, Piruzeli MLB, Goldman JD, Saraiva JFK, Chakladar S, Marconi VC; COV-BARRIER Study Group. Efficacy and safety of baricitinib plus standard of care for the treatment of critically ill hospitalised adults with COVID-19 on invasive mechanical ventilation or extracorporeal membrane oxygenation: an exploratory, randomised, placebo-controlled trial. Lancet Respir Med. 2022 Apr;10(4):327-336. doi: 10.1016/S2213-2600(22)00006-6. Epub 2022 Feb 3.
- Background: PubMed 28199814Taylor PC, Keystone EC, van der Heijde D, Weinblatt ME, Del Carmen Morales L, Reyes Gonzaga J, Yakushin S, Ishii T, Emoto K, Beattie S, Arora V, Gaich C, Rooney T, Schlichting D, Macias WL, de Bono S, Tanaka Y. Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis. N Engl J Med. 2017 Feb 16;376(7):652-662. doi: 10.1056/NEJMoa1608345.
- 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.
Yan Qu, PhD MD principal investigator
Department of Neurosurgery, Tangdu Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baricitinib 4 MG and Standard treatment in people with Spontaneous Subarachnoid Hemorrhage, run by Tang-Du Hospital.
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 11 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 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Haixiao Liu, PhD MD (+86-02984778359, lhxiao@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of pneumonia (time frame: up to 14 days). 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 NCT06439615, which also lists 8 linked publications.
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 3 Jun 2024.