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

January 16, 2018 updated by: Techpool Bio-Pharma Co., Ltd.
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2186

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital
    • Fujian
      • Xiamen, Fujian, China, 361000
        • NO.2 Hospital XiaMen
    • Hebei
      • Handan, Hebei, China, 056001
        • Handan Central Hospital
      • Hengshui, Hebei, China, 053000
        • Harrison International Peace Hospital
    • Hunan
      • Chenzhou, Hunan, China, 423000
        • Chenzhou No.1 People's Hospital
    • Jiangsu
      • Zhenjiang, Jiangsu, China, 212000
        • Affiliated Hospital of Jiangsu University
    • Zhejiang
      • Yiwu, Zhejiang, China, 322000
        • The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Acute anterior circulation cerebral infarction diagnosed ≤ 48h;
  2. First time diagnosed or have history of acute anterior circulation cerebral infarction without serious sequelae(mRS=0-2);
  3. Age from 18 to 80 years old;
  4. National Institute of Health stroke scale(NIHSS) from 6 to 25;
  5. Have provided signed written informed consent from the patient or the patient's legal representative.

Exclusion Criteria:

  1. Brain CT shows cerebral hemorrhage disease: cerebral hemorrhage, subarachnoid hemorrhage, etc.
  2. Transient ischemic attack(TIA);
  3. Serious disturbance of consciousness: Glasgow Coma ScaleGCS（GCS）≤8;
  4. Combined angiotensin-converting enzyme inhibitor(ACEI) less than 5 half-time(according to its instruction), or need to be treated with ACEI;
  5. Cases treated with thrombolysis / stent surgery or expected to be treated with thrombolysis / interventional therapy / stent surgery.
  6. subjects with bleeding disorders at Past or present, laboratory tests: INR > 1.5 or APTT > 2 times;
  7. subjects with abnormal liver function (ALT/AST > 1.5 * ULN) and abnormal renal function (Cr> normal upper limit);
  8. subjects with history of epilepsy or other serious systemic disease before onset of AIS refused by PI to enroll ;
  9. subjects with cardiogenic stroke or cardiogenic stroke related high-risk factors identified by PI, such as atrial fibrillation, echocardiography or Mural thrombus etc;
  10. subjects diagnosised any malignancy (except basal cell carcinoma) within 5 years prior to the start of the study;
  11. subjects with severe dementia or can't cooperate to evaluate identified by PI;
  12. suffering from severe hypertension and failed to control :systolic blood pressure ≥200mmHg (26.6kPa) or diastolic blood pressure ≥110mmHg (14.6kPa); hypotension: systolic blood pressure< 90mmHg and/or diastolic blood pressure< 60mmHg
  13. subjects be allergic or intolerant to kallikrein at past;
  14. subjects be pregnant/lactating or possibly and planned pregnant;
  15. subjects be unsuitable for this clinical study identified by PI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: kallikrein group
Subjects receive kallikrein treatment according to real clinical practice (suggest above 14days treatment),0.15 peptide nucleic acids(PNA), once a day.
Drug: kallikrein
Using kallikrein
Other Names:
  • KLK
  • Human urinary kallikrein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events
Time Frame: From enrolled to the day 90
From enrolled to the day 90

Secondary Outcome Measures

Outcome Measure
Time Frame
Cerebral infarction on the National Institute of Health stroke scale
Time Frame: The day 8,15 and 22 after enrolled
The day 8,15 and 22 after enrolled
Recurrence rate of acute cerebral infarction
Time Frame: From enrolled to the day 90
From enrolled to the day 90
Activities of daily living on the Barthel Index
Time Frame: The day 15,22 and 90 after enrolled
The day 15,22 and 90 after enrolled
Patients body status on the Modified Rankin Scale
Time Frame: The day 15, 22 and 90 after enrolled
The day 15, 22 and 90 after enrolled
EQ-5D-3L score
Time Frame: The day 15, 22 and 90 after enrolled
The day 15, 22 and 90 after enrolled
Evaluation of pharmaceutical economics
Time Frame: The day 15, 22 and 90 after enrolled
The day 15, 22 and 90 after enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Techpool Bio-Pharma Co., Ltd.

Investigators

  • Principal Investigator: Liying Cui, Doctor, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

November 30, 2018

Study Completion (Anticipated)

November 30, 2018

Study Registration Dates

First Submitted

September 10, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 29, 2015

Study Record Updates

Last Update Posted (Actual)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KLK-4002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Infarction

Clinical Trials on kallikrein

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe