GD-11 for Injection in the Treatment of Acute Ischemic Stroke

NCT ID: NCT06299579

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 980 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2025-12-31

Brief Summary

Phase III Clinical Trial of GD-11 for Injection in the Treatment of Acute Ischemic Stroke - A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase III Clinical Study with the primary objective of evaluation of the efficacy and safety of GD-11 for injection in the treatment of acute ischemic stroke patients within 48 hours. The subject has a clinical diagnosis of acute ischemic stroke, within 48 hours from stroke onset to start of study treatment, with a National Institutes of Health Stroke Scale (NIHSS) between 6 and 20, had a total score of upper and lower limbs on motor deficits ≥ 2. The primary outcome is the proportion of subjects with mRS score ≤ 1 at 90 days after treatment.

Detailed Description

A multicenter, randomized, double-blind, parallel, placebo-controlled trial design was used. Subjects were randomly assigned in a 1:1 ratio to the experimental group (GD-11 for injection treatment group) and the control group (GD-11 for injection placebo group). Randomization stratification factors included onset time (≤24 hours, >24 hours) and center.Continuous treatment was performed for 10 days (20 times), followed up to 90 days after the first administration.

The trial was divided into three phases: screening/baseline phase, treatment phase, and follow-up phase.

Screening/baseline phase: Subjects entered the screening/baseline phase after signing the informed consent for screening examinations.

Treatment phase: Eligible subjects were randomly assigned in a 1:1 ratio to receive GD-11 for injection or placebo for injection for 10 days (20 times). During the treatment, protocol-required examinations were performed and safety was evaluated.

Follow-up phase: Subjects who completed the treatment entered the follow-up phase and were followed up to 90 days after the first administration.

Stroke-related scale scores were performed on the 10th, 30th, and 90th days after the first use of the test drug. Adverse events were recorded during the treatment and follow-up phases to further evaluate safety.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

GD-11 for injection test group

GD-11 for injection, freeze-dried powder, 80mg, 160mg/dose Before the test drug is used, from the specification of 100 ml saline infusion bag, use a sterile syringe to extract about 15 ml saline into the test drug, by the oscillator or artificial vibration for about 5min, completely dissolved and then injected back to the administration of the infusion bag with a sterile syringe, gently shaking and mixing, and then intravenously titrated for 30min ± 10min.

The first dose should be completed as soon as possible after randomization; the second dose should not be less than 6 hours from the start of the first dose, but not more than 12 + 1h; each subsequent dose interval of 12 ± 1h (calculated using the fixed time of administration as the baseline point and each dose should not be less than 6 hours from the start of the last dose); 10 consecutive days of treatment, a total of 20 times.

Group Type: EXPERIMENTAL

GD-11 for injection test group

Intervention Type: DRUG

The first dose of GD-11 was administered as soon as possible after randomization and then every 12±1 hour. A total of 20 doses were required.

Placebo control group

Placebo, freeze-dried powder, 80mg, 160mg/dose Before the test drug is used, from the specification of 100 ml saline infusion bag, use a sterile syringe to extract about 15 ml saline into the test drug, by the oscillator or artificial vibration for about 5min, completely dissolved and then injected back to the administration of the infusion bag with a sterile syringe, gently shaking and mixing, and then intravenously titrated for 30min ± 10min.

The first dose should be completed as soon as possible after randomization; the second dose should not be less than 6 hours from the start of the first dose, but not more than 12 + 1h; each subsequent dose interval of 12 ± 1h (calculated using the fixed time of administration as the baseline point and each dose should not be less than 6 hours from the start of the last dose); 10 consecutive days of treatment, a total of 20 times.

Group Type: PLACEBO_COMPARATOR

Placebo control group

Intervention Type: DRUG

The first dose of placebo was administered as soon as possible after randomization and then every 12±1 hour. A total of 20 doses were required.

Interventions

GD-11 for injection test group

The first dose of GD-11 was administered as soon as possible after randomization and then every 12±1 hour. A total of 20 doses were required.

Intervention Type: DRUG

Placebo control group

The first dose of placebo was administered as soon as possible after randomization and then every 12±1 hour. A total of 20 doses were required.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Only those who meet all of the following items will be enrolled:

1. age ≥18 years and <81 years, male or female;

2. National Institutes of Health Stroke Scale (NIHSS) score: 6 ≤ NIHSS ≤ 20, and the sum of item 5 Upper Extremity and item 6 Lower Extremity scores ≥ 2 after the onset of this event;

3. The onset of the disease is within 48 hours (including 48 hours);

4. Patients who are diagnosed with ischemic stroke according to the requirements of the latest guidelines such as "Diagnostic Points of Various Major Cerebrovascular Diseases in China 2019" or "Clinical Management Guidelines of Cerebrovascular Diseases in China (2nd edition)", and who have a good healing after the first onset or the last onset (mRS score ≤1 before this onset);

5. Obtaining informed consent approved by the Ethics Committee voluntarily signed by the patients or their legal representatives.

Exclusion Criteria

Those who met one of the following items at screening will not be eligible for enrollment:

1. intracranial hemorrhagic disease as seen on cranial imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.; if blood seepage only, the suitability for enrollment may be based on the investigator's judgment;

2. severe impairment of consciousness: item score >1 on the 1a level of consciousness of the NIHSS;

3. thrombolysis, thrombolysis or intervention has been applied or is planned to be applied after this episode;

4. transient ischemic attack (TIA);

5. the patient's blood pressure remains ≥ 220 mmHg systolic or ≥ 120 mmHg diastolic after control;

6. patients with a previous diagnosis of severe mental disorders as well as patients with dementia;

7. patients who have been diagnosed with severe active liver disease, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc.; or ALT (Alanine amino Transferase) or AST (Aspartate amino Transferase) > 2.0 x ULN (Upper Limit of Normal Value);

8. patients who have been diagnosed with severe active renal disease, renal insufficiency; or serum creatinine > 1.5 × ULN;

9. after the onset of the disease, the drug with neuroprotective effect has been used in the marketing, such as commercially available edaravone, edaravone dextran edaravone/(+)-2-Decanol injection concentrated solution, nimodipine, gangliosides, cytidine diphosphate, piracetam, oxiracetam, butylphenyl peptide, human urinary kallidinogenase (Urinary Kallidinogenase), cinepazide, murine nerve growth factor, cerebral vivax (hydrolysate of cerebral proteins), calf's blood deprivation of protein injection, calf's blood deprivation of protein extract injection and so on.

10. previously diagnosed with concurrent malignant tumors and undergoing anti-tumor therapy; for subjects diagnosed with malignant tumors after enrollment, continued participation in the study may be based on the investigator's judgment and the subject's wishes;

11. previously diagnosed with a serious systemic disease with an expected survival of <90 days;

12. the patient is pregnant, breastfeeding and the patient/patient's partner has the potential for pregnancy and plans to become pregnant during the trial period

13. patients with a previously known hypersensitivity to GD-11 for Injection and its excipients;

14. history of major surgery within 4 weeks prior to enrollment that in the investigator's assessment affects neurologic function scores or affects 90-day survival;

15. participation in another clinical study within 30 days prior to randomization or ongoing participation in another clinical study; Not considered by the investigator to be suitable for participation in this clinical study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Wangao Pharmaceutical Co. ltd

UNKNOWN

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yongjun Wang

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shuya Li

Role: STUDY_DIRECTOR

IRB of Beijing Tiantan Hospital Capital Medical University Beijing

Locations

Beijing Tiantan Hospital Capital Medical University Beijing

Beijing, Beijing Municipality, China

Site Status: NOT_YET_RECRUITING

Linfen Central Hospital

Shangxi, Linfen City, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongjun Wang

Role: CONTACT

yongjunwang111@aliyun.com

+86 10 5997 8538

Shuya Li

Role: CONTACT

shuyali85@163.com

13601367028

Facility Contacts

Yongjun Wang

Role: primary

yongjunwang111@aliyun.com

hongguo Dai

Role: primary

daihongguo3199@163.com

References

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Reference Type: RESULT

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Enlimomab Acute Stroke Trial Investigators. Use of anti-ICAM-1 therapy in ischemic stroke: results of the Enlimomab Acute Stroke Trial. Neurology. 2001 Oct 23;57(8):1428-34. doi: 10.1212/wnl.57.8.1428.

Reference Type: RESULT

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Reference Type: RESULT

PMID: 11315017 (View on PubMed)

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Reference Type: RESULT

PMID: 22105690 (View on PubMed)

Other Identifiers

WG-GD11-III-01

Identifier Type: -

Identifier Source: org_study_id