Clinical trial NCT02562183: The Study to Reevaluate the Safety and Efficacy of Human Urinary Kallikrein
Official title: The Study to Reevaluate the Safety and Efficacy of Human Urinary Kallikrein
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cerebral Infarction
Lead sponsor: Techpool Bio-Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-09-29
Enrollment: 2186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: From enrolled to the day 90
Secondary outcomes:
measure: Cerebral infarction on the National Institute of Health stroke scale
timeFrame: The day 8,15 and 22 after enrolled
measure: Recurrence rate of acute cerebral infarction
timeFrame: From enrolled to the day 90
measure: Activities of daily living on the Barthel Index
timeFrame: The day 15,22 and 90 after enrolled
measure: Patients body status on the Modified Rankin Scale
timeFrame: The day 15, 22 and 90 after enrolled
measure: EQ-5D-3L score
timeFrame: The day 15, 22 and 90 after enrolled
measure: Evaluation of pharmaceutical economics
timeFrame: The day 15, 22 and 90 after enrolled
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Xiamen
country: China
facility: NO.2 Hospital XiaMen
state: Fujian
city: Handan
country: China
facility: HanDan Central Hospital
state: Hebei
city: Hengshui
country: China
facility: Harrison International Peace Hospital
state: Hebei
city: Chenzhou
country: China
facility: Chenzhou NO.1 People's Hospital
state: Hunan
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Yiwu
country: China
facility: The Fourth Affiliated hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Peking Union Medical College Hospital
name: Liying Cui, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ni J, Qu J, Yao M, Zhang Z, Zhong X, Cui L; RESK investigators. Re-evaluate the Efficacy and Safety of Human Urinary Kallidinogenase (RESK): Protocol for an Open-Label, Single-Arm, Multicenter Phase IV Trial for the Treatment of Acute Ischemic Stroke in Chinese Patients. Transl Stroke Res. 2017 Aug;8(4):341-346. doi: 10.1007/s12975-017-0527-5. Epub 2017 Mar 6.