A Phase 2 interventional study of Sodium Nitrite in Subarachnoid Hemorrhage, sponsored by Hope Pharmaceuticals. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-30.
Sponsored by Hope Pharmaceuticals · Phase 2, Interventional, and Treatment
The hypothesis is that intravenous infusion of sodium nitrite is safe and effective for the reversal of cerebral vasospasm after subarachnoid hemorrhage in patients with a cerebral aneurysm.
This is a pilot single center, open-labeled study. Patients with subarachnoid hemorrhage admitted to the hospital and who meet entry criteria will be offered enrollment into the study. The patients will be enrolled promptly after detection of the presence of cerebral vasospasm. Subjects will receive sodium nitrite infusion.
One dose cohort is planned, 64 nmol/min/kg sodium nitrite (0.1325 mg/hour/kg; 0.0442 ml/hour/kg at a concentration of 3mg/ml).
510 studies on the registry are indexed under Subarachnoid Hemorrhage; 128 are open to participants now.
This study's enrollment of 6 is below the median of 57 across 264 interventional studies indexed under Subarachnoid Hemorrhage.
Browse Subarachnoid Hemorrhage studies →Hope Pharmaceuticals is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One dose cohort is planned, 64 nmol/min/kg sodium nitrite (0.1325 mg/hour/kg; 0.0442 ml/hour/kg at a concentration of 3mg/ml).
Drug: Sodium Nitrite
Subjects will receive continuous intravenous infusion of study drug for 7 days at a dose of 64 nmol/min/kg. The infusion will begin shortly after angiographic demonstration of cerebral vasospasm and will be for 7 days unless side effects of the drug dictate stopping the infusion.
Also known as: Sodium Nitrite Injection 300 mg/10 mL
Cerebral Vasospasm
Cerebral digital subtraction angiographies will be reviewed at at least 2 time points, including at the time of diagnosis of angiographic vasospasm immediately before treatment with nitrite and after up to 180 minutes of nitrite infusion. Radiographs will be compared to determine whether increased flow of radiographic dye is visualized following initiation of nitrite infusion.
Time frame: 180 minutes
| Milestone | Sodium Nitrite |
|---|---|
| Started | 6 |
| Completed | 0 |
| Not completed | 6 |
Cerebral digital subtraction angiographies will be reviewed at at least 2 time points, including at the time of diagnosis of angiographic vasospasm immediately before treatment with nitrite and after up to 180 minutes of nitrite infusion. Radiographs will be compared to determine whether increased flow of radiographic dye is visualized following initiation of nitrite infusion.
| Participants | Sodium Nitrite |
|---|---|
| Increased flow between baseline and 2nd radiograph | 2 |
| Unchanged flow between baseline and 2nd radiograph | 4 |
Collected over 12 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sodium Nitrite | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | Sodium Nitrite |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 6 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Sodium Nitrite |
|---|---|
| Female | 4 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Sodium Nitrite |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 5 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Sodium Nitrite |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 6 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Sodium Nitrite |
|---|---|
| United States | 6 |
The record gives a start of Jun 2014, a primary completion of Jan 2017 and a completion of Jan 2017. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2018, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sodium Nitrite
Hope Pharmaceuticals