The Study to Reevaluate the Safety and Efficacy of Human Urinary Kallikrein

Enrolling by invitation

Phase 4 Results N/A

Trial Description

In order to reevaluate safety and efficacy of human urinary kallikrein in treating acute cerebral infarction ,a multi-center, open label , single group study was designed. Expect to enroll 60 sites and 2186 subjects. Subjects will receive kallikrein treatment according to real clinical practice (suggest above 14days treatment) and 90 days follow up

Conditions

Interventions

  • Kallikrein Drug
    Other Names: KLK; Human urinary kallikrein
    Intervention Desc: Using kallikrein
    ARM 1: Kind: Experimental
    Label: kallikrein group
    Description: Subjects receive a treatment of 21 days with kallikrein, 0.15 peptide nucleic acids(PNA), once a day.

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of Participants with Adverse Events From enrolled to the day 90 Yes
Secondary Cerebral infarction on the National Institute of Health stroke scale The day 8,15 and 22 after enrolled Yes
Secondary Activities of daily living on the Barthel Index The day 22 and 90 after enrolled Yes
Secondary Patients body status on the Modified Rankin Scale The day 22 and 90 after enrolled Yes
Secondary Recurrence rate of acute cerebral infarction From enrolled to the day 90 Yes
Secondary EQ-5D-3L score The day 15, 22 and 90 after enrolled
Secondary Evaluation of pharmaceutical economics The day 15, 22 and 90 after enrolled

Sponsors