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

Cerebral Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02562183
• Other study ID #: KLK-4002
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: September 10, 2015
• Last updated: January 16, 2018
• Start date: August 2015
• Est. completion date: November 30, 2018

Study information

• Verified date: January 2018
• Source: Techpool Bio-Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2186
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Intervention

Drug:
• kallikrein
Using kallikrein

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Chenzhou NO.1 People's Hospital	Chenzhou	Hunan
China	HanDan Central Hospital	Handan	Hebei
China	Harrison International Peace Hospital	Hengshui	Hebei
China	NO.2 Hospital XiaMen	Xiamen	Fujian
China	The Fourth Affiliated hospital of Zhejiang University School of Medicine	Yiwu	Zhejiang
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Techpool Bio-Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events		From enrolled to the day 90
Secondary	Cerebral infarction on the National Institute of Health stroke scale		The day 8,15 and 22 after enrolled
Secondary	Recurrence rate of acute cerebral infarction		From enrolled to the day 90
Secondary	Activities of daily living on the Barthel Index		The day 15,22 and 90 after enrolled
Secondary	Patients body status on the Modified Rankin Scale		The day 15, 22 and 90 after enrolled
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