Clinical Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke "DIAS-J"

Completed

Phase 2 Results N/A

Trial Description

The purpose of the study is to evaluate whether desmoteplase is safe and tolerated when given to Japanese patients with acute ischemic stroke

Detailed Description

The study is a safety and tolerability study of desmoteplase in Japanese patients with acute ischemic stroke. The study will test two doses

Conditions

Interventions

  • Desmoteplase Drug
    Intervention Desc: 1 bolus injection of desmoteplase 90 µg/kg (IV)
    ARM 1: Kind: Experimental
    Label: Desmoteplase 70 µg/kg
    ARM 2: Kind: Experimental
    Label: Desmoteplase 90 µg/kg
  • Placebo Drug
    Intervention Desc: 1 bolus injection of placebo IV
    ARM 1: Kind: Experimental
    Label: Placebo

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary To evaluate the safety and tolerability of desmoteplase doses of 70 µg/kg and 90 µg/kg in Japanese patients with acute ischemic stroke as measured by the presence of symptomatic intracranial haemorrhage (sICH) within 72 hours after IMP 90 days Yes
Secondary To evaluate the clinical improvement at Day 90 after administration of Investigational Medicinal Product (IMP) as measured by modified Rankin Scale (mRS) 90 days No
Secondary To evaluate the clinical improvement at Day 7 and 30 after administration of IMP as measured by modified Rankin Scale (mRS) Day 7 and Day 30 No
Secondary To evaluate recanalisation at 18±6 hr after administration of IMP 18±6 hr after administration of IMP No
Secondary To evaluate change in infarct size at 18±6 hr relative to pre-treatment infarct size 18±6 hr after administration No
Secondary To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of desmoteplase 0.5 - 9 hr No
Secondary To evaluate the immunogenicity of desmoteplase Day 7, Day 30, Day 90 No
Secondary To explore the predictive value of different volumes of absolute mismatch for the clinical response and other objectives Day 90 No

Sponsors