THR-18's Pharmacokinetics and Pharmacodynamics in Subjects With Acute Ischemic Stroke Treated With tPA
Condition: Stroke, Acute
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the experimental drug "THR-18" given together with the
      drug "tissue plasminogen activator" for the treatment of stroke. Tissue plasminogen activator
      is also called "tPA".

      Strokes often result from blockade of blood supply caused by blood clots forming within the
      blood vessel feeding the brain. Such strokes are called "Ischemic strokes". Treatment of
      these strokes is aimed at breaking up the blood clot(s) and renewing the blood flow before
      further parts of the brain die. Breaking up the blood clot is possible with the drug tPA when
      it is injected into a vein shortly after the stroke starts. However, along with breaking up
      the blood clot, tPA sometimes causes adverse effects, for example, it may cause bleeding.
      THR-18, the drug tested in this study, is meant to bind to tPA and reduce its adverse effects
      without stopping tPA's breaking up of the blocking blood clot.

      The primary purpose of this study is to evaluate the safety of THR-18 in acute ischemic
      stroke patients who are treated in parallel with tPA. Another purpose of this study is to
      investigate levels of THR-18 and tPA in the blood stream at different time points after they
      are injected, at the same time, into a vein. In addition, this study will measure tPA's
      effect on blood clot dissolution when tPA is given with and without THR-18. The study will
      also study the effect THR-18 may have on signals of brain damage that can be found in the
      blood after stroke: these signals of brain damage are small proteins called S100B and matrix
      metalloproteinase (MMP)-9. These proteins are released into the blood stream when the brain
      is injured.

      The safety evaluation of THR-18 in this study will be done in comparison to placebo. Placebo
      is a drug that looks exactly like THR-18 but has no activity. Three doses of THR-18 will be
      tested, one after the other, in three groups of patients. In each group, some patients will
      receive THR-18 and some will receive placebo. This clinical study will be conducted only at
      one hospital in the Ukraine. In total, 30 patients are planned to participate in this study.
      These patients will be in the hospital for at least 3 days after receiving the study
      treatment. Then, about 1 month later, they will be invited for a last follow-up visit.
    


Intervention name(s): THR-18; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): THR-18 is an 18-mer peptide derived from the sequence of human plasminogen activator inhibitor 1 (PAI-1), having the ability to bind to a site of tissue plasminogen activator (tPA) distal to its catalytic site and uncouple the beneficial clot-dissolving properties of tPA from its deleterious non-fibrinolytic effects.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment