Ischemic StrokePhase 2NCT02572336
A Study of the Safety, Imaging and Clinical Outcomes of THR-18 in Acute Stroke Subjects Treated With tPA
A Phase 2 study testing THR-18 and Tissue Plasminogen Activator (tPA) in people with Ischemic Stroke, run by D-Pharm Ltd. at 1 site in Moldova.
Trial summary
This study will test the experimental drug "THR-18" given together with the drug "tissue plasminogen activator" for the treatment of stroke. Tissue plasminogen activator is also called "tPA". Strokes often result from blockade of blood supply caused by blood clots forming within the blood vessel feeding the brain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- THR-18 and Tissue Plasminogen Activator (tPA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMoldova
- Study dates
- Oct 2015to Apr 2016
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years, both inclusive.
- Acute ischemic stroke, defined as an acute, focal, neurological deficit(s), secondary to an ischemic vascular event, which must include at baseline at least 1 of the following components as reflected by at least 1 point on items 9, 3 and 11 of the National Institutes of Health Stroke Scale (NIHSS), i.e. language dysfunction (aphasic disorder, excluding dysarthria), visual field defect (excluding monocular blindness), extinction and inattention.
- NIHSS above 5 and below 18 for left and right hemisphere strokes.
- Indication for the administration of intravenous tPA for acute stroke in accordance with tPA's authorized label for acute stroke.
- Pre-stroke modified Rankin Scale score lower or equal to 2.
- Ability to understand the requirements of the study and willing to provide written informed consent. In the event of incapacitated subjects, informed consent will be sought from a legally acceptable representative or by any other means as approved by the Ethics Committee.
- No contraindication to i.v. administration of iodinated contrast agent
Who cannot join
- Contraindications for tPA administration because of an increased risk of bleeding
- Known hypersensitivity to tPA or to iodinated contrast agents.
- Neurological deficit that has led to stupor or coma (NIHSS level of consciousness score above or equal to 2).
- Stroke 90 days before screening/baseline assessments that is either confirmed or assumed to be in the same cerebral territory as is the current acute stroke.
- Seizure any time between stroke symptoms onset and randomization.
- Life expectancy below 1 month.
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- Serious illness, e.g. heart failure grade III or IV according to the New York Heart - Association functional classification, severe hepatic or renal failure.
- Neurological or non-neurological disease that in the investigator's opinion may confound the assessment of the treatment's safety or biological effects.
- Estimated creatinine clearance equal to or lower than 45 mL/min or dependency on renal dialysis.
- Treatment of the qualifying stroke with intravenous heparin unless activated partial thromboplastin time prolongation is not more than 2 seconds above the upper limit of normal for local laboratory prior to study drug initiation.
- Treatment of the qualifying stroke with a low molecular weight heparin or heparinoid.
- Female of childbearing potential who is not willing to use adequate and effective birth control measures for the duration of the trial.
- Positive urine pregnancy test at screening/baseline or lactating female.
- Body weight (measured or estimated) above 100 kg.
- Current drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
Moldova1 site, 1 recruiting
- Recruiting
Municipal Emergency Hospital
Chisinau
Prof. Stanslav Groppa, MD, PhD
About this study
Official title: Phase II Study to Assess the Safety, Imaging, Pharmacodynamic and Clinical Outcomes of Acute Ischemic Stroke Subjects Treated With tPA and THR-18
This study will test the experimental drug "THR-18" given together with the drug "tissue plasminogen activator" for the treatment of stroke. Tissue plasminogen activator is also called "tPA".
Strokes often result from blockade of blood supply caused by blood clots forming within the blood vessel feeding the brain. Such strokes are called "Ischemic strokes". Treatment of these strokes is aimed at breaking up the blood clot(s) and renewing the blood flow before further parts of the brain die. Breaking up the blood clot is possible with the drug tPA when it is injected into a vein shortly after the stroke starts. However, along with breaking up the blood clot, tPA sometimes causes adverse effects, for example, it may cause bleeding. THR-18, the drug tested in this study, is meant to reduce tPA's adverse effects without stopping tPA's breaking up of the blocking blood clot.
Read more
The aims of this study are to evaluate the safety of THR-18 in acute ischemic stroke patients who are treated in parallel with tPA, to measure tPA's effect on blood clot dissolution when this drug is given with and without THR-18, and to study the effects THR-18 may have on signals of brain damage as seen on brain computerized tomography (a type of brain x-ray) after treatment with tPA with and without THR-18. Patients will also be evaluated for their ability to perform daily activities after the stroke following tPA treatment with and without THR-18.
The evaluation of THR-18 in this study will be done in comparison to placebo. Placebo is a drug that looks exactly like THR-18 but has no activity. One dose of THR-18 will be tested, in 20 patients. In parallel, 20 other patients will receive placebo. In total, 40 patients are planned to participate in this study. The decision whether a patient will receive THR-18 or placebo will be based on chance (this procedure is called "randomization"). This clinical study will be conducted only at one hospital, in the Republic of Moldova. The patients will be in the hospital for at least 3 days after receiving the study treatment. Then, about 1 month later, they will be invited for a last follow-up visit.
- Conditions
- Ischemic Stroke
- Being tested
- THR-18, Placebo, Tissue Plasminogen Activator (tPA)
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THR-18Drug
THR-18 is an 18-mer peptide derived from the sequence of human plasminogen activator inhibitor 1 (PAI-1), having the ability to bind to a site of tissue plasminogen activator (tPA) distal to its catalytic site and uncouple the beneficial clot-dissolving properties of tPA from its deleterious non-fibrinolytic effects.
PlaceboDrug
Placebo is a THR-18 lookalike, to be administered with tPA.
Tissue Plasminogen Activator (tPA)Drug
tPA is a thrombolytic agent. tPA is not an investigational drug.
| Study group | Role | What they receive |
|---|---|---|
| THR-18 | Active comparator | Single administration of intravenous THR-18 solution Receives: Drug: THR-18; Drug: Tissue Plasminogen Activator (tPA) |
| Placebo | Placebo comparator | Single administration of intravenous THR-18 lookalike solution Receives: Drug: Placebo; Drug: Tissue Plasminogen Activator (tPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical examination
Measured: 30 days after administration
ASPECTS score
Measured: 2 days after administration
ECASS-II bleeding grades
Measured: 2 days after administration
Severity of cerebral edema per computerized tomography according to the IST-3 grades
Measured: 2 days after administration
Final infarct volume per computerized tomography
Measured: 30 days after administration
Neurological deficits per the NIH stroke scale
Measured: 30 days after administration
Functional capacity per the modified Rankin Score
Measured: 30 days after administration
Change in blood levels of matrix metalloproteinase 9
Measured: 3 days after administration
heart rate
Measured: 30 days after administration
blood pressure
Measured: 30 days after administartion
electrocardiogram
Measured: 30 days after administration
persons with adverse events
Measured: 30 days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D-Pharm Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572336
- Sponsor's protocol ID
- Ptcl-01462
- Status last verified
- Oct 2015
- First submitted
- 3 Oct 2015
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Assess the Safety, Imaging, Pharmacodynamic and Clinical Outcomes of Acute Ischemic Stroke Subjects Treated With tPA and THR-18
- ClinicalTrials.gov ID
- NCT02572336
- Acronym / sponsor ID
- Ptcl-01462
- Conditions
- Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- D-Pharm Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 8 Oct 2015 (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.
This study will test the experimental drug "THR-18" given together with the drug "tissue plasminogen activator" for the treatment of stroke. Tissue plasminogen activator is also called "tPA".
Strokes often result from blockade of blood supply caused by blood clots forming within the blood vessel feeding the brain. Such strokes are called "Ischemic strokes". Treatment of these strokes is aimed at breaking up the blood clot(s) and renewing the blood flow before further parts of the brain die. Breaking up the blood clot is possible with the drug tPA when it is injected into a vein shortly after the stroke starts. However, along with breaking up the blood clot, tPA sometimes causes adverse effects, for example, it may cause bleeding. THR-18, the drug tested in this study, is meant to reduce tPA's adverse effects without stopping tPA's breaking up of the blocking blood clot.
The aims of this study are to evaluate the safety of THR-18 in acute ischemic stroke patients who are treated in parallel with tPA, to measure tPA's effect on blood clot dissolution when this drug is given with and without THR-18, and to study the effects THR-18 may have on signals of brain damage as seen on brain computerized tomography (a type of brain x-ray) after treatment with tPA with and without THR-18. Patients will also be evaluated for their ability to perform daily activities after the stroke following tPA treatment with and without THR-18.
The evaluation of THR-18 in this study will be done in comparison to placebo. Placebo is a drug that looks exactly like THR-18 but has no activity. One dose of THR-18 will be tested, in 20 patients. In parallel, 20 other patients will receive placebo. In total, 40 patients are planned to participate in this study. The decision whether a patient will receive THR-18 or placebo will be based on chance (this procedure is called "randomization"). This clinical study will be conducted only at one hospital, in the Republic of Moldova. The patients will be in the hospital for at least 3 days after receiving the study treatment. Then, about 1 month later, they will be invited for a last follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THR-18 | Active comparator | Drug: THR-18, Drug: Tissue Plasminogen Activator (tPA)Single administration of intravenous THR-18 solution |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Tissue Plasminogen Activator (tPA)Single administration of intravenous THR-18 lookalike solution |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 80 years, both inclusive.
- Acute ischemic stroke, defined as an acute, focal, neurological deficit(s), secondary to an ischemic vascular event, which must include at baseline at least 1 of the following components as reflected by at least 1 point on items 9, 3 and 11 of the National Institutes of Health Stroke Scale (NIHSS), i.e. language dysfunction (aphasic disorder, excluding dysarthria), visual field defect (excluding monocular blindness), extinction and inattention.
- NIHSS above 5 and below 18 for left and right hemisphere strokes.
- Indication for the administration of intravenous tPA for acute stroke in accordance with tPA's authorized label for acute stroke.
- Pre-stroke modified Rankin Scale score lower or equal to 2.
Key exclusion criteria (15 listed)
- Contraindications for tPA administration because of an increased risk of bleeding
- Known hypersensitivity to tPA or to iodinated contrast agents.
- Neurological deficit that has led to stupor or coma (NIHSS level of consciousness score above or equal to 2).
- Stroke 90 days before screening/baseline assessments that is either confirmed or assumed to be in the same cerebral territory as is the current acute stroke.
- Seizure any time between stroke symptoms onset and randomization.
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 |
|---|---|---|
| THR-18THR-18 is an 18-mer peptide derived from the sequence of human plasminogen activator inhibitor 1 (PAI-1), having the ability to bind to a site of tissue plasminogen activator (tPA) distal to its catalytic site and uncouple the beneficial clot-dissolving properties of tPA from its deleterious non-fibrinolytic effects. | Drug | THR-18 |
| PlaceboPlacebo is a THR-18 lookalike, to be administered with tPA. | Drug | Placebo |
| Tissue Plasminogen Activator (tPA)tPA is a thrombolytic agent. tPA is not an investigational drug. | Drug | Placebo, THR-18 |
Primary outcome
physical examination
Time frame: 30 days after administration
ASPECTS score
Time frame: 2 days after administration
ECASS-II bleeding grades
Time frame: 2 days after administration
Severity of cerebral edema per computerized tomography according to the IST-3 grades
Time frame: 2 days after administration
Final infarct volume per computerized tomography
Time frame: 30 days after administration
Neurological deficits per the NIH stroke scale
Time frame: 30 days after administration
Functional capacity per the modified Rankin Score
Time frame: 30 days after administration
Change in blood levels of matrix metalloproteinase 9
Time frame: 3 days after administration
heart rate
Time frame: 30 days after administration
blood pressure
Time frame: 30 days after administartion
electrocardiogram
Time frame: 30 days after administration
persons with adverse events
Time frame: 30 days after administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing THR-18 and Tissue Plasminogen Activator (tPA) in people with Ischemic Stroke, run by D-Pharm Ltd. at 1 site in Moldova.
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 15 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: status not confirmed, as of the sponsor's last update on 17 Nov 2015. 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 Moldova. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gilad Rosenberg, MD (+972544474409, grosenberg@dpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical examination (time frame: 30 days after administration). The study lists 12 primary outcomes in all. 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 17 Nov 2015.