Safety and Efficacy Study in Acute Ischaemic Stroke "VASST"

Completed

Phase 2 Results N/A

Trial Description

A Phase II study to evaluate the safety and efficacy of five dose levels of study drug in acute ischaemic stroke

Detailed Description

An open label, dose escalation study where patients with acute ischaemic stroke will receive a single intravenous dose of study drug. There will be five dose levels with groups of 10 patients in each. Escalation to higher doses will occur following review of safety data from the previous dose.

Conditions

Interventions

  • V10153 Drug
    Other Names: Code Names: V10153, BB-10153; CAS Registry Number: 931101-84-7; Proposed INN: Troplasminogen alfa
    Intervention Desc: Single acute intravenous bolus dose up to 10 mg/kg
    ARM 1: Kind: Experimental
    Label: V10153
    Description: Single acute intravenous bolus dose up to 10 mg/kg
    ARM 2: Kind: Experimental
    Label: V10153, 1.0 mg/kg
    Description: Single acute intravenous bolus dose
    ARM 3: Kind: Experimental
    Label: V10153, 2.5 mg/kg
    Description: Single acute intravenous bolus dose
    ARM 4: Kind: Experimental
    Label: V10153, 5.0 mg/kg
    Description: Single acute intravenous bolus dose
    ARM 5: Kind: Experimental
    Label: V10153, 7.5 mg/kg
    Description: Single acute intravenous bolus dose
    ARM 6: Kind: Experimental
    Label: V10153, 10 mg/kg
    Description: Single acute intravenous bolus dose

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

There will be four dose levels with groups of 10 patients in each, and escalation to higher doses will occur following review of safety data from the previous dose.

Outcomes

Type Measure Time Frame Safety Issue
Primary Clinical assessment for intracranial haemorrhage (ICH), major systemic bleeding, other serious adverse events.
Secondary Recanalizaiton rates from CT angiograms will be compared; clinical outcome according to NIHSS, modified Rankin Scale (mRS), and Barthel Index; and safety will be determined by CT scan for evidence of ICH, adverse events, laboratory variables, vital signs, and ECG.
Primary To establish the safety of five dose levels (1.0, 2.5, 5, 7.5 and 10 mg/kg)of V10153 in patients with acute ischaemic stroke. Ongoing Yes
Secondary To compare recanalisation rates across dose levels. Ongoing No
Secondary To compare clinical outcome between treatments by NIHSS, Modified Rankin Scale and Barthel Index. Post-study completion No

Sponsors