Health TrialsbyHealthPanel

Phase III Clinical Trial of SHPL-49 Injection in the Treatment of Acute Ischemic Stroke

ConditionAcute Ischemic Stroke
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Hutchison Pharmaceuticals Limited

About this trial

This study is designed to determine the efficacy and safety of SHPL-49 intravenous infusion in acute ischemic stroke patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-80 years old (including upper and lower limits);

Clinically diagnosed as acute ischemic stroke according to the latest guidelines;

Patients diagnosed as acute ischemic stroke who plan to receive or have received standard intravenous thrombolysis in hospital (this research center) within 8hours of symptom onset;

Patients who have NIHSS score≥5 and ≤ 22 before thrombolysis;

Disqualifiers

Complicated with intracranial hemorrhagic diseases, including hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.;

Severe disturbance of consciousness: patients with NIHSS 1a consciousness level item score ≥2;

Cerebral Computed tomography (CT) or Magnetic resonance imaging (MRI) indicated a large anterior circulation cerebral infarction (infarct area greater than 1/3 of the middle cerebral artery blood supply area);

Stroke with rapid improvement of symptoms before intravenous thrombolysis, or acute ischemic symptoms suspected to be caused by other causes;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHPL-49 Injection

    Drug

    2 ampoules of SHPL-49 Injection in 100 mL 0.9% sodium chloride will be administered as a 30-minute intravenous infusion and applied twice daily for 7 days.

  • Placebo Injection

    Drug

    2 ampoules of Placebo Injection in 100 mL 0.9% sodium chloride will be administered as a 30-minute intravenous infusion and applied twice daily for 7days.

Treatment groups

1,096 Participants
are divided into 2 treatment groups
Group A: SHPL-49 InjectionExperimental treatment 1 intervention
Group B: Placebo InjectionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Modified Rankin Scale (mRS), with scores of 0-1 at Day 90

Proportion of participants with mRS scores of 0-1 at Day 90

Time frame
90±7 days

Secondary outcomes

1

Modified Rankin Scale (mRS), with scores at Day 90

A shift of one or more categories to reduced functional dependence analyzed across the whole distribution of outcomes on the mRS at Day 90

Time frame
90±7 days
2

Modified Rankin Scale (mRS), with scores of 0-2 at Day 90

Proportion of participants with mRS Scores of 0-2 at Day 90

Time frame
90±7 days
3

Barthel index (BI) at Day 90

Proportion of participants with BI ≥95 at Day 90

Time frame
90±7 days
4

Modified Rankin Scale (mRS), with scores of 0-1 at Day 30

Proportion of participants with mRS Scores of 0-1 at Day 30

Time frame
30±3 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Hutchison Pharmaceuticals Limited

Lead sponsor

Beijing Tiantan Hospital

Collaborator

Source ClinicalTrials.gov
Apply now