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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02562183
Recruitment Status : Unknown
Verified January 2018 by Techpool Bio-Pharma Co., Ltd..
Recruitment status was:  Enrolling by invitation
First Posted : September 29, 2015
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Techpool Bio-Pharma Co., Ltd.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Cerebral Infarction Drug: kallikrein Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2186 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Study to Reevaluate the Safety and Efficacy of Human Urinary Kallikrein
Study Start Date : August 2015
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

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




Primary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: From enrolled to the day 90 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562183


Locations
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China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
China, Fujian
NO.2 Hospital XiaMen
Xiamen, Fujian, China, 361000
China, Hebei
HanDan Central Hospital
Handan, Hebei, China, 056001
Harrison International Peace Hospital
Hengshui, Hebei, China, 053000
China, Hunan
Chenzhou NO.1 People's Hospital
Chenzhou, Hunan, China, 423000
China, Jiangsu
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China, 212000
China, Zhejiang
The Fourth Affiliated hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, China, 322000
Sponsors and Collaborators
Techpool Bio-Pharma Co., Ltd.
Investigators
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Principal Investigator: Liying Cui, Doctor Peking Union Medical College Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Techpool Bio-Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT02562183    
Other Study ID Numbers: KLK-4002
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Cerebral Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Kallikreins
Coagulants
Fertility Agents, Male
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs