Subarachnoid Hemorrhage, AneurysmalPhase 1NCT01865630
Safety and Efficacy Study of Etanercept for Aneurysmal Subarachnoid Hemorrhage
A Phase 1 study testing Etanercept in people with Subarachnoid Hemorrhage, Aneurysmal, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Subarachnoid hemorrhage (SAH) is a special type of stroke that typically results from a ruptured intracranial aneurysm, a weakening in the wall of a blood vessel. This type of life-threatening bleeding occurs in over 3000 Canadians per year, usually in working age adults. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal
- What is being tested?
- Etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2021to Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 to 75 years old.
- World Federation of Neurological Surgeons (WFNS) grade 2 to 4.
- Subarachnoid hemorrhage (SAH) on admission computed tomographic (CT) scan (diffuse clot present in both hemispheres or local thick SAH).
- Ruptured saccular aneurysm, confirmed by angiography (catheter or CT angiography [CTA]) and treated by neurosurgical clipping or endovascular coiling.
- External ventricular drain placed as part of routine care.
- Able to be dosed within 36 hours of injury
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- Historical modified Rankin score of 0 or 1.
- Hemodynamically stable after resuscitation (systolic blood pressure [SBP] > 100 mm Hg).
- Aminotransferase levels no greater than twice the upper limit of normal, hemoglobin > 85 g/dL, platelets > 125,000 cells/mm3, serum creatinine < 177 μmol/L.
- Informed consent.
Who cannot join
- SAH due to causes other than saccular aneurysm (such as trauma or rupture of fusiform or infective aneurysm).
- Intraventricular or intracerebral hemorrhage, in the absence of SAH, or with only local, thin SAH.
- Angiographic vasospasm prior to clipping or endovascular procedure.
- Major complication during clipping or endovascular coiling, such as massive intraoperative hemorrhage, arterial occlusion or inability to clip or coil the ruptured aneurysm.
- Cardio-pulmonary resuscitation required following SAH.
- Women with a positive urine pregnancy test at screening.
Show all 10Show fewer
- Body mass index > 35
- Severe or unstable concomitant condition or disease (e.g., known significant neurologic deficit, cancer, hematologic, or coronary disease), or chronic condition (e.g., psychiatric disorder), which, in the opinion of the investigator, would affect the assessment of the safety and tolerability of etanercept.
- Patients who have received an investigational product or participated in another clinical trial within 28 days prior to randomization or those who have already participated in the current study.
- History of hepatitis B or C, history of heart failure (etanercept may exacerbate heart failure), active infection or serious infection in the last 6 months, history of tuberculosis and history of malignancy, multiple sclerosis or history of seizures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Safety, Blood Brain Barrier Permeability and Potential Efficacy of Etanercept for Aneurysmal Subarachnoid Hemorrhage
Subarachnoid hemorrhage (SAH) is a special type of stroke that typically results from a ruptured intracranial aneurysm, a weakening in the wall of a blood vessel. This type of life-threatening bleeding occurs in over 3000 Canadians per year, usually in working age adults. Although this type of stroke accounts for only 5-10% of strokes, it contributes a disproportionately larger percent of overall stroke morbidity and mortality due in part to the young age of those affected. If one is fortunate enough to survive the initial bleeding episode and the subsequent surgical treatment of the aneurysm, a patient may still develop secondary strokes 3 to 14 days after the initial bleed. These delayed strokes are the most significant cause of morbidity and mortality after SAH and may be potentially preventable. Currently, there is only one medication (an anti-hypertensive) that has convincingly shown to improve outcomes after SAH. The molecular pathway causing these delayed strokes is still not clear, and this is an active area of research.
Animal studies have revealed that these delayed strokes may be caused by a pro-inflammation molecule called tumor necrosis factor alpha (TNFa). Delayed strokes were prevented experimentally by a TNFa blocker called etanercept. This clinical study, utilizing prophylactic treatment with etanercept in patients with SAH, will ensure the safety of this drug and determine its effectiveness in preventing delayed strokes.
Read the detailed description
SAH from a ruptured cerebral aneurysm has an incidence of 10 per 100,000 Canadians (over 3000 people annually). If a person survives SAH from a ruptured intracranial aneurysm, the most common complication is delayed cerebral ischemia (DCI). This is the delayed neurologic deterioration associated with angiographic vasospasm. Vasospasm refers to the arterial constriction that typically begins 3 days after SAH, is maximal 7 to 8 days later and generally resolves by 14 days. About two-thirds of patients with SAH develop vasospasm, one-third develop DCI and one-sixth of SAH patients die or sustain permanent disability from DCI, despite aggressive medical/surgical intervention.
Nimodipine, a calcium-channel antagonist, is currently the only drug to convincingly improve outcomes after SAH. Randomized multi-centre clinical trials utilizing clazosentan, an endothelin receptor antagonist, demonstrated no change in clinical outcome despite significant decrease in large vessel vasospasm. These results have shifted the research in the pathophysiology of DCI to alternative mechanisms other than large vessel vasospasm.
It is known that the presence of blood in the subarachnoid space triggers massive local and systemic inflammation, including increase in the production of a pro-inflammatory cytokine called tumor necrosis factor alpha (TNFa). We have shown in mice that global, and smooth muscle-specific knockout of TNFa prevents increased myogenic tone and reduces brain injury after SAH. Furthermore, systemic or intrathecal treatment with etanercept may prevent the increase in myogenic tone observed after SAH and may reduce brain injury. Administration of etanercept to patients with SAH is a critical step in determining the safety and potential efficacy of TNFa antagonists in SAH.
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Being tested
- Etanercept
- Keywords
- Prophylactic treatment with Etanercept in aSAH., Safety of Etanercept in the prevention of DCI in aSAH.
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Also called Enbrel (Amgen Inc., CA)
Lyophilized powder for reconstitution/ 25 mg/vial. 25 mg subcutaneously starting within 36 hours of SAH, and then receive doses 3.5 days and 7 days later for a total of 3 doses.
| Study group | Role | What they receive |
|---|---|---|
| Etanercept | Experimental | Patients with aneurysmal subarachnoid hemorrhage will be treated with etanercept, 25 mg subcutaneously starting within 36 hours of SAH, and then receive doses 3.5 days and 7 days later for a total of 3 doses. Receives: Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, blood brain barrier (BBB) permeability and potential efficacy of the TNFa antagonist, etanercept, in humans with subarachnoid hemorrhage (SAH).
Phase 1 safety, feasibility study in which patients with aneurysmal subarachnoid hemorrhage (aSAH) will be treated with etanercept, 25 mg subcutaneously starting within 36 hours of SAH, then receive doses 3.5 days and 7 days later for a total of 3 doses. Patients must have the aneurysm secured by neurosurgical clipping or endovascular coiling and have an external ventricular drain placed as part of routine care. Other aspects of routine care include clinical monitoring (vital signs, neurological exam), daily bloodwork, daily cerebrospinal fluid (CSF) samples, and brain imaging typically magnetic resonance imaging/angiography (MRI/MRA) within 48 hours of coiling, and CTA at day 7-11 post-bleed. Etanercept levels determined by ELISA, will be measured in the blood and CSF samples, as well as IL-1 levels.
Adverse events will be recorded in case-report forms. Total study duration for each patient is 12 weeks, including hospital stay and clinical follow-up at 4 and 12 weeks post-SAH.
Measured: Up to Week 12 post-SAH
Secondary outcomes (1)
Pharmacokinetics (plasma and CSF concentrations) of etanercept by measuring daily plasma and CSF concentrations by enzyme-linked immunosorbent assay (ELISA).
Pharmacokinetic sampling to monitor plasma and cerebrospinal fluid levels of etanercept will be performed daily after first administration of etanercept until post-SAH day 14 or hospital discharge, whichever comes first.
Measured: Up to Week 12 post-subarachnoid hemorrhage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startJan 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Why it stopped: PI moved to another institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Baker, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865630
- Sponsor's protocol ID
- 13-3007-ETP
- Status last verified
- Oct 2020
- First submitted
- 27 May 2013
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beeftink MM, Ruigrok YM, Rinkel GJ, van den Bergh WM. Relation of serum TNF-alpha and TNF-alpha genotype with delayed cerebral ischemia and outcome in subarachnoid hemorrhage. Neurocrit Care. 2011 Dec;15(3):405-9. doi: 10.1007/s12028-011-9556-1.
PubMed 21562930Gruber A, Rossler K, Graninger W, Donner A, Illievich MU, Czech T. Ventricular cerebrospinal fluid and serum concentrations of sTNFR-I, IL-1ra, and IL-6 after aneurysmal subarachnoid hemorrhage. J Neurosurg Anesthesiol. 2000 Oct;12(4):297-306. doi: 10.1097/00008506-200010000-00001.
PubMed 11147377Kerensky TA, Gottlieb AB, Yaniv S, Au SC. Etanercept: efficacy and safety for approved indications. Expert Opin Drug Saf. 2012 Jan;11(1):121-39. doi: 10.1517/14740338.2012.633509. Epub 2011 Nov 11.
PubMed 22074366Vecchione C, Frati A, Di Pardo A, Cifelli G, Carnevale D, Gentile MT, Carangi R, Landolfi A, Carullo P, Bettarini U, Antenucci G, Mascio G, Busceti CL, Notte A, Maffei A, Cantore GP, Lembo G. Tumor necrosis factor-alpha mediates hemolysis-induced vasoconstriction and the cerebral vasospasm evoked by subarachnoid hemorrhage. Hypertension. 2009 Jul;54(1):150-6. doi: 10.1161/HYPERTENSIONAHA.108.128124. Epub 2009 May 26.
PubMed 19470883Zhou QH, Sumbria R, Hui EK, Lu JZ, Boado RJ, Pardridge WM. Neuroprotection with a brain-penetrating biologic tumor necrosis factor inhibitor. J Pharmacol Exp Ther. 2011 Nov;339(2):618-23. doi: 10.1124/jpet.111.185876. Epub 2011 Aug 10.
PubMed 21831964
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Safety, Blood Brain Barrier Permeability and Potential Efficacy of Etanercept for Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT01865630
- Acronym / sponsor ID
- 13-3007-ETP
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Keywords
- Prophylactic treatment with Etanercept in aSAH., Safety of Etanercept in the prevention of DCI in aSAH.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI moved to another institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 31 May 2013 (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.
Subarachnoid hemorrhage (SAH) is a special type of stroke that typically results from a ruptured intracranial aneurysm, a weakening in the wall of a blood vessel. This type of life-threatening bleeding occurs in over 3000 Canadians per year, usually in working age adults. Although this type of stroke accounts for only 5-10% of strokes, it contributes a disproportionately larger percent of overall stroke morbidity and mortality due in part to the young age of those affected. If one is fortunate enough to survive the initial bleeding episode and the subsequent surgical treatment of the aneurysm, a patient may still develop secondary strokes 3 to 14 days after the initial bleed. These delayed strokes are the most significant cause of morbidity and mortality after SAH and may be potentially preventable. Currently, there is only one medication (an anti-hypertensive) that has convincingly shown to improve outcomes after SAH. The molecular pathway causing these delayed strokes is still not clear, and this is an active area of research.
Animal studies have revealed that these delayed strokes may be caused by a pro-inflammation molecule called tumor necrosis factor alpha (TNFa). Delayed strokes were prevented experimentally by a TNFa blocker called etanercept. This clinical study, utilizing prophylactic treatment with etanercept in patients with SAH, will ensure the safety of this drug and determine its effectiveness in preventing delayed strokes.
Detailed description
SAH from a ruptured cerebral aneurysm has an incidence of 10 per 100,000 Canadians (over 3000 people annually). If a person survives SAH from a ruptured intracranial aneurysm, the most common complication is delayed cerebral ischemia (DCI). This is the delayed neurologic deterioration associated with angiographic vasospasm. Vasospasm refers to the arterial constriction that typically begins 3 days after SAH, is maximal 7 to 8 days later and generally resolves by 14 days. About two-thirds of patients with SAH develop vasospasm, one-third develop DCI and one-sixth of SAH patients die or sustain permanent disability from DCI, despite aggressive medical/surgical intervention.
Nimodipine, a calcium-channel antagonist, is currently the only drug to convincingly improve outcomes after SAH. Randomized multi-centre clinical trials utilizing clazosentan, an endothelin receptor antagonist, demonstrated no change in clinical outcome despite significant decrease in large vessel vasospasm. These results have shifted the research in the pathophysiology of DCI to alternative mechanisms other than large vessel vasospasm.
It is known that the presence of blood in the subarachnoid space triggers massive local and systemic inflammation, including increase in the production of a pro-inflammatory cytokine called tumor necrosis factor alpha (TNFa). We have shown in mice that global, and smooth muscle-specific knockout of TNFa prevents increased myogenic tone and reduces brain injury after SAH. Furthermore, systemic or intrathecal treatment with etanercept may prevent the increase in myogenic tone observed after SAH and may reduce brain injury. Administration of etanercept to patients with SAH is a critical step in determining the safety and potential efficacy of TNFa antagonists in SAH.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etanercept | Experimental | Drug: EtanerceptPatients with aneurysmal subarachnoid hemorrhage will be treated with etanercept, 25 mg subcutaneously starting within 36 hours of SAH, and then receive doses 3.5 days and 7 days later for a total of 3 doses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female 18 to 75 years old.
- World Federation of Neurological Surgeons (WFNS) grade 2 to 4.
- Subarachnoid hemorrhage (SAH) on admission computed tomographic (CT) scan (diffuse clot present in both hemispheres or local thick SAH).
- Ruptured saccular aneurysm, confirmed by angiography (catheter or CT angiography [CTA]) and treated by neurosurgical clipping or endovascular coiling.
- External ventricular drain placed as part of routine care.
Key exclusion criteria (10 listed)
- SAH due to causes other than saccular aneurysm (such as trauma or rupture of fusiform or infective aneurysm).
- Intraventricular or intracerebral hemorrhage, in the absence of SAH, or with only local, thin SAH.
- Angiographic vasospasm prior to clipping or endovascular procedure.
- Major complication during clipping or endovascular coiling, such as massive intraoperative hemorrhage, arterial occlusion or inability to clip or coil the ruptured aneurysm.
- Cardio-pulmonary resuscitation required following SAH.
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 |
|---|---|---|
| EtanerceptAlso: Enbrel (Amgen Inc., CA)Lyophilized powder for reconstitution/ 25 mg/vial. 25 mg subcutaneously starting within 36 hours of SAH, and then receive doses 3.5 days and 7 days later for a total of 3 doses. | Drug | Etanercept |
Primary outcome
Safety, blood brain barrier (BBB) permeability and potential efficacy of the TNFa antagonist, etanercept, in humans with subarachnoid hemorrhage (SAH).
Time frame: Up to Week 12 post-SAH
Phase 1 safety, feasibility study in which patients with aneurysmal subarachnoid hemorrhage (aSAH) will be treated with etanercept, 25 mg subcutaneously starting within 36 hours of SAH, then receive doses 3.5 days and 7 days later for a total of 3 doses. Patients must have the aneurysm secured by neurosurgical clipping or endovascular coiling and have an external ventricular drain placed as part of routine care. Other aspects of routine care include clinical monitoring (vital signs, neurological exam), daily bloodwork, daily cerebrospinal fluid (CSF) samples, and brain imaging typically magnetic resonance imaging/angiography (MRI/MRA) within 48 hours of coiling, and CTA at day 7-11 post-bleed. Etanercept levels determined by ELISA, will be measured in the blood and CSF samples, as well as IL-1 levels. Adverse events will be recorded in case-report forms. Total study duration for each patient is 12 weeks, including hospital stay and clinical follow-up at 4 and 12 weeks post-SAH.
1 secondary outcome
Pharmacokinetics (plasma and CSF concentrations) of etanercept by measuring daily plasma and CSF concentrations by enzyme-linked immunosorbent assay (ELISA).
Time frame: Up to Week 12 post-subarachnoid hemorrhage
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Background: PubMed 21562930Beeftink MM, Ruigrok YM, Rinkel GJ, van den Bergh WM. Relation of serum TNF-alpha and TNF-alpha genotype with delayed cerebral ischemia and outcome in subarachnoid hemorrhage. Neurocrit Care. 2011 Dec;15(3):405-9. doi: 10.1007/s12028-011-9556-1.
- Background: PubMed 11147377Gruber A, Rossler K, Graninger W, Donner A, Illievich MU, Czech T. Ventricular cerebrospinal fluid and serum concentrations of sTNFR-I, IL-1ra, and IL-6 after aneurysmal subarachnoid hemorrhage. J Neurosurg Anesthesiol. 2000 Oct;12(4):297-306. doi: 10.1097/00008506-200010000-00001.
- Background: PubMed 22074366Kerensky TA, Gottlieb AB, Yaniv S, Au SC. Etanercept: efficacy and safety for approved indications. Expert Opin Drug Saf. 2012 Jan;11(1):121-39. doi: 10.1517/14740338.2012.633509. Epub 2011 Nov 11.
- Background: PubMed 19470883Vecchione C, Frati A, Di Pardo A, Cifelli G, Carnevale D, Gentile MT, Carangi R, Landolfi A, Carullo P, Bettarini U, Antenucci G, Mascio G, Busceti CL, Notte A, Maffei A, Cantore GP, Lembo G. Tumor necrosis factor-alpha mediates hemolysis-induced vasoconstriction and the cerebral vasospasm evoked by subarachnoid hemorrhage. Hypertension. 2009 Jul;54(1):150-6. doi: 10.1161/HYPERTENSIONAHA.108.128124. Epub 2009 May 26.
- Background: PubMed 21831964Zhou QH, Sumbria R, Hui EK, Lu JZ, Boado RJ, Pardridge WM. Neuroprotection with a brain-penetrating biologic tumor necrosis factor inhibitor. J Pharmacol Exp Ther. 2011 Nov;339(2):618-23. doi: 10.1124/jpet.111.185876. Epub 2011 Aug 10.
- 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. This study is not recruiting at the moment.
Andrew Baker, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Etanercept in people with Subarachnoid Hemorrhage, Aneurysmal, run by Unity Health Toronto at 1 site in Canada.
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 10 inclusion and 10 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: withdrawn, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Safety, blood brain barrier (BBB) permeability and potential efficacy of the TNFa antagonist, etanercept, in humans with subarachnoid hemorrhage (SAH). (time frame: Up to Week 12 post-SAH). 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 NCT01865630, which also lists 5 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 2 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.