Intracerebral HemorrhagePhase 3NCT03546283
Neuroprotectant for Hypertensive Intracerebral Hemorrhage
A Phase 3 study testing Cattle Encephalon Glycoside and Ignotin in people with Intracerebral Hemorrhage, run by Rong Hu, MD at 1 site in China.
Trial summary
Cattle encephalon glycoside and ignotin Cattle encephalon glycoside and ignotin (CEGI) injection (drug approval H22025046; Jilin Sihuan Pharmaceutical Co. LTD., Jilin, People's Republic of China) is a compound preparation of muscle extract from healthy rabbits and cattle brain gangliosides, which was approved by the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Cattle Encephalon Glycoside and Ignotin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 422 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2018to 31 Dec 2020
- Phase
- Phase 3
- 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
- Individuals aged 18-75 years;
- Newly diagnosed hypertensive intracerebral hemorrhage, bleeding position localizes in Basal ganglia and bleeding volume is within 25-50ml evaluated by head CT, and the hemorrhage does not break into lateral ventricle;
- Obvious neurological dysfunction after onset, Glasco Comma Scale evaluation between 5-14, or NIHSS above 6, but without signs of cerebral hernia.
- Enrolled within 72 hours after onset, and CT examination shows no hematomas expansion within 6 hours or above after diagnostic CT (hematoma expansion ≤ 5ml);
- Written informed consent can be obtained.
Who cannot join
- Diagnosed with intracerebral hemorrhage caused by aneurysm, brain tumor, trauma, cerebral parasitic disease, cerebrovascular malformation, moyamoya disease, cerebral arteritis, hematological diseases, or metabolic disorders;
- Patients whose hematoma is unstable or progress leading to increased intracranial pressure;
- Ever diagnosed with subarachnoid hemorrhage and ischemic stroke;
- Ever received anticoagulants or antiplatelet drug treatment within one month prior to onset;
- Abnormal coagulation function (platelet count <100×109/L, INR>1.4);
- Patients who need operation treatment (including external ventricular drainage);
Show all 14Show fewer
- Patients who may suffer from mental or physical diseases that disturb outcome evaluation;
- blood homocysteine higher than 15μmol/L when admission;
- Patients who have serious diseases in heart, lung, liver, kidney, endocrine or hemopoietic system;
- Allergic to protein or peptide;
- Drug or alcohol addiction;
- Pregnant women (positive in pregnancy test or lactating women)
- Participated in other clinical trials within 3 months;
- Patients considered as not suitable for clinical trials by researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurosurgery , Southwest Hospital, Third Military Medical University,
Chongqing, Chongqing Municipality, 400038
About this study
Official title: Efficacy and Safety of Neuroprotectant Cattle Encephalon Glycoside and Ignotin Injection for Intracerebral Hemorrhage: a Multicenter, Randomized, Double-blinded, Placebo-controlled Trial.
Cattle encephalon glycoside and ignotin Cattle encephalon glycoside and ignotin (CEGI) injection (drug approval H22025046; Jilin Sihuan Pharmaceutical Co. LTD., Jilin, People's Republic of China) is a compound preparation of muscle extract from healthy rabbits and cattle brain gangliosides, which was approved by the Chinese Food and Drug Administration in 2011 and was commonly used as neuroprotectant in the treatment of central and peripheral nerve injuries in China. To evaluate the safety and efficacy of CEGI in treatment of Hypertensive intracerebral hemorrhage, we designed this study.
Read the detailed description
Hypertensive intracerebral hemorrhage (HICH) is a type of stroke that is caused by hypertension-induced intracranial arterial, venous, and capillary ruptures. In recent years, the incidence of HICH has become higher, which has exposed society greatly to heavy social and economic burdens. Therefore it is necessary to find therapeutic strategies. ICH causes primary white matter injury by direct mechanical compression and hematoma expansion, and then it induces secondary injury through toxic product from the blood out of the vessel. The inflammatory response that follows ICH also contributes to the white matter injury. Additionally, post-ICH complications that include cortical thinning, cerebral edema, and hydrocephalus further aggravate the subcortical white matter damage.
The complex injury mechanisms that follow ICH implies that a multi-target neuroprotective agent might be able to achieve better neuroprotective effects than current single-agent neuroprotective therapies.
Cattle encephalon glycoside and ignotin Cattle encephalon glycoside and ignotin (CEGI) injection (drug approval H22025046; Jilin Sihuan Pharmaceutical Co. LTD., Jilin, People's Republic of China) is a multi-target neuroprotective agent that includes polypeptides, various gangliosides, free amino acids and nucleic acids, which were extracted from muscle tissue of healthy rabbits and cattle brain gangliosides, and was approved by the Chinese Food and Drug Administration in 2011, commonly used as neuroprotectant in the treatment of central and peripheral nerve injuries in China.
It has been proven by basic research that CEGI treatment significantly alleviated the neurobehavioral dysfunction, promoted hematoma absorption, effectively up-regulated MBP/MAP-2 expression, and ameliorated white matter fiber damage [1]. CEGI was frequently used in the treatment of intracerebral hemorrhage, yet there is still a lack of high quality study to demonstrate its clinical efficacy. To achieve more clinical evidence of CEGI in treatment of Hypertensive intracerebral hemorrhage, we designed this study to further evaluate the efficacy and safety of CEGI in the treatment of Hypertensive intracerebral hemorrhage.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Placebos, Cattle Encephalon Glycoside and Ignotin
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlacebosDrug
The patients with hypertensive intracerebral hemorrhage will be randomized into giving placebos, the other treatments in this group follow the guidelines on the treatment of hypertensive intracerebral hemorrhage.
Cattle Encephalon Glycoside and IgnotinDrug
The patients with hypertensive intracerebral hemorrhage will be randomized into giving CEGI, the other treatments in this group follow the guidelines on the treatment of hypertensive intracerebral hemorrhage.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | The patients with hypertensive intracerebral hemorrhage will be randomized into giving placebo group, the other treatments in this group follow the guidelines on the treatment of hypertensive intracerebral hemorrhage. Receives: Drug: Placebos |
| CEGI treatment | Experimental | The patients with hypertensive intracerebral hemorrhage will be randomized into giving drug CEGI, the other treatments in this group follow the guidelines on the treatment of hypertensive intracerebral hemorrhage. Receives: Drug: Cattle Encephalon Glycoside and Ignotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
GOSE at 90 days
Glasgow Outcome Scale Extended at 90 days
Measured: 90 days after onset
Secondary outcomes (5)
GOSE at 30 days
Glasgow Outcome Scale Extended at 30 days
Measured: 30 days after onset
Score of mRS at 14days, 30 days and 90 days
Global functional performance after stroke in terms of mRS at 14 days, 30 Days and 90 Days, respectively: 0 - No symptoms.1- No significant disability. Able to carry out all usual activities, despite some symptoms.2- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3- Moderate disability. Requires some help, but able to walk unassisted.4- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6- Dead.
Measured: 14 days, 30 days and 90 days after onset
Score of NIHSS at 14days, 30 days and 90 days
Global functional performance after stroke in terms of NIH Stroke Scale at 14 Days, 30 Days, and 90 Days, respectively: (0 = best possible, highest number = best possible) in areas of motor control of the arm (0-4), leg (0-4) sensory perception (0-2), language (0-3), limb ataxia (0-2), gaze (0-2), level of consciousness (0-3), level of consciousness -orientation (0-2), level of consciousness -commands (0-2), facial palsy (0-3), visual (0-3), dysarthria (0-2), and extinction (0-2).
Measured: 14 days, 30 days and 90 days after onset
Score of Barthel Index at 14days, 30 days and 90 days
Global functional performance after stroke in terms of Barthel Index (scores 0~100) at 14 Days, 30 Days, and 90 Days, respectively: scores 100 mean good daily living ability; scores above 60 mean mild function disability that can live independently most time; scores between 60~41 mean moderate function disability that need some help in daily life; scores below 20 mean total disability that live helplessly.
Measured: 14 days, 30 days and 90 days after onset
Complications
Complications incidence including epilepsy, hydrocephalus, cerebral infarction, blooding recurrence, pneumonia and gastrointestinal bleeding
Measured: within 90 days after onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start15 Jun 2018 (estimated)
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Dec 2020 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 422 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rong Hu, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rong Hu, MD, Southwest Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546283
- Sponsor's protocol ID
- Neurosurg 04
- Status last verified
- Jun 2018
- First submitted
- 16 May 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Neuroprotectant Cattle Encephalon Glycoside and Ignotin Injection for Intracerebral Hemorrhage: a Multicenter, Randomized, Double-blinded, Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT03546283
- Acronym / sponsor ID
- Neurosurg 04
- Conditions
- Intracerebral Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 422 participants (estimated)
- Lead sponsor
- Rong Hu, MDUniversity, hospital or other
- Study start
- 15 Jun 2018 (estimated)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 6 Jun 2018 (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.
Cattle encephalon glycoside and ignotin Cattle encephalon glycoside and ignotin (CEGI) injection (drug approval H22025046; Jilin Sihuan Pharmaceutical Co. LTD., Jilin, People's Republic of China) is a compound preparation of muscle extract from healthy rabbits and cattle brain gangliosides, which was approved by the Chinese Food and Drug Administration in 2011 and was commonly used as neuroprotectant in the treatment of central and peripheral nerve injuries in China. To evaluate the safety and efficacy of CEGI in treatment of Hypertensive intracerebral hemorrhage, we designed this study.
Detailed description
Hypertensive intracerebral hemorrhage (HICH) is a type of stroke that is caused by hypertension-induced intracranial arterial, venous, and capillary ruptures. In recent years, the incidence of HICH has become higher, which has exposed society greatly to heavy social and economic burdens. Therefore it is necessary to find therapeutic strategies. ICH causes primary white matter injury by direct mechanical compression and hematoma expansion, and then it induces secondary injury through toxic product from the blood out of the vessel. The inflammatory response that follows ICH also contributes to the white matter injury. Additionally, post-ICH complications that include cortical thinning, cerebral edema, and hydrocephalus further aggravate the subcortical white matter damage.
The complex injury mechanisms that follow ICH implies that a multi-target neuroprotective agent might be able to achieve better neuroprotective effects than current single-agent neuroprotective therapies.
Cattle encephalon glycoside and ignotin Cattle encephalon glycoside and ignotin (CEGI) injection (drug approval H22025046; Jilin Sihuan Pharmaceutical Co. LTD., Jilin, People's Republic of China) is a multi-target neuroprotective agent that includes polypeptides, various gangliosides, free amino acids and nucleic acids, which were extracted from muscle tissue of healthy rabbits and cattle brain gangliosides, and was approved by the Chinese Food and Drug Administration in 2011, commonly used as neuroprotectant in the treatment of central and peripheral nerve injuries in China.
It has been proven by basic research that CEGI treatment significantly alleviated the neurobehavioral dysfunction, promoted hematoma absorption, effectively up-regulated MBP/MAP-2 expression, and ameliorated white matter fiber damage [1]. CEGI was frequently used in the treatment of intracerebral hemorrhage, yet there is still a lack of high quality study to demonstrate its clinical efficacy. To achieve more clinical evidence of CEGI in treatment of Hypertensive intracerebral hemorrhage, we designed this study to further evaluate the efficacy and safety of CEGI in the treatment of Hypertensive intracerebral hemorrhage.
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 |
|---|---|---|
| Control | Placebo comparator | Drug: PlacebosThe patients with hypertensive intracerebral hemorrhage will be randomized into giving placebo group, the other treatments in this group follow the guidelines on the treatment of hypertensive intracerebral hemorrhage. |
| CEGI treatment | Experimental | Drug: Cattle Encephalon Glycoside and IgnotinThe patients with hypertensive intracerebral hemorrhage will be randomized into giving drug CEGI, the other treatments in this group follow the guidelines on the treatment of hypertensive intracerebral hemorrhage. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals aged 18-75 years;
- Newly diagnosed hypertensive intracerebral hemorrhage, bleeding position localizes in Basal ganglia and bleeding volume is within 25-50ml evaluated by head CT, and the hemorrhage does not break into lateral ventricle;
- Obvious neurological dysfunction after onset, Glasco Comma Scale evaluation between 5-14, or NIHSS above 6, but without signs of cerebral hernia.
- Enrolled within 72 hours after onset, and CT examination shows no hematomas expansion within 6 hours or above after diagnostic CT (hematoma expansion ≤ 5ml);
- Written informed consent can be obtained.
Key exclusion criteria (14 listed)
- Diagnosed with intracerebral hemorrhage caused by aneurysm, brain tumor, trauma, cerebral parasitic disease, cerebrovascular malformation, moyamoya disease, cerebral arteritis, hematological diseases, or metabolic disorders;
- Patients whose hematoma is unstable or progress leading to increased intracranial pressure;
- Ever diagnosed with subarachnoid hemorrhage and ischemic stroke;
- Ever received anticoagulants or antiplatelet drug treatment within one month prior to onset;
- Abnormal coagulation function (platelet count <100×109/L, INR>1.4);
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 |
|---|---|---|
| PlacebosThe patients with hypertensive intracerebral hemorrhage will be randomized into giving placebos, the other treatments in this group follow the guidelines on the treatment of hypertensive intracerebral hemorrhage. | Drug | Control |
| Cattle Encephalon Glycoside and IgnotinThe patients with hypertensive intracerebral hemorrhage will be randomized into giving CEGI, the other treatments in this group follow the guidelines on the treatment of hypertensive intracerebral hemorrhage. | Drug | CEGI treatment |
Primary outcome
GOSE at 90 days
Time frame: 90 days after onset
Glasgow Outcome Scale Extended at 90 days
5 secondary outcomes
GOSE at 30 days
Time frame: 30 days after onset
Score of mRS at 14days, 30 days and 90 days
Time frame: 14 days, 30 days and 90 days after onset
Score of NIHSS at 14days, 30 days and 90 days
Time frame: 14 days, 30 days and 90 days after onset
Score of Barthel Index at 14days, 30 days and 90 days
Time frame: 14 days, 30 days and 90 days after onset
Complications
Time frame: within 90 days after onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Intracerebral Hemorrhage
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
Recruiting
Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage
Intracerebral Haemorrhage, Minimally Invasive Treatment
RecruitingObservational study
Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage (ICH)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cattle Encephalon Glycoside and Ignotin in people with Intracerebral Hemorrhage, run by Rong Hu, MD at 1 site in China.
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 5 inclusion and 14 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 6 Jun 2018. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
GOSE at 90 days (time frame: 90 days after onset). 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 6 Jun 2018.