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

Primary Purpose

Cerebral Infarction

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

kallikrein

About this trial

This is an interventional treatment trial for Cerebral Infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Peking Union Medical College Hospital
NO.2 Hospital XiaMen
HanDan Central Hospital
Harrison International Peace Hospital
Chenzhou NO.1 People's Hospital
Affiliated Hospital of Jiangsu University
The Fourth Affiliated hospital of Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

kallikrein group

Arm Description

Subjects receive kallikrein treatment according to real clinical practice (suggest above 14days treatment),0.15 peptide nucleic acids(PNA), once a day.

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events

Secondary Outcome Measures

Cerebral infarction on the National Institute of Health stroke scale

Recurrence rate of acute cerebral infarction

Activities of daily living on the Barthel Index

Patients body status on the Modified Rankin Scale

EQ-5D-3L score

Evaluation of pharmaceutical economics

Full Information

NCT ID

NCT02562183

First Posted

September 10, 2015

Last Updated

January 16, 2018

Sponsor

Techpool Bio-Pharma Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02562183

Brief Title

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

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 2015 (undefined)

Primary Completion Date

November 30, 2018 (Anticipated)

Study Completion Date

November 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Techpool Bio-Pharma Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Infarction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

kallikrein group

Arm Type

Experimental

Arm Description

Subjects receive kallikrein treatment according to real clinical practice (suggest above 14days treatment),0.15 peptide nucleic acids(PNA), once a day.

Intervention Type

Drug

Intervention Name(s)

kallikrein

Other Intervention Name(s)

KLK, Human urinary kallikrein

Intervention Description

Using kallikrein

Primary Outcome Measure Information:

Title

Number of Participants with Adverse Events

Time Frame

From enrolled to the day 90

Secondary Outcome Measure Information:

Title

Cerebral infarction on the National Institute of Health stroke scale

Time Frame

The day 8,15 and 22 after enrolled

Title

Recurrence rate of acute cerebral infarction

Time Frame

From enrolled to the day 90

Title

Activities of daily living on the Barthel Index

Time Frame

The day 15,22 and 90 after enrolled

Title

Patients body status on the Modified Rankin Scale

Time Frame

The day 15, 22 and 90 after enrolled

Title

EQ-5D-3L score

Time Frame

The day 15, 22 and 90 after enrolled

Title

Evaluation of pharmaceutical economics

Time Frame

The day 15, 22 and 90 after enrolled

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Acute anterior circulation cerebral infarction diagnosed ≤ 48h; First time diagnosed or have history of acute anterior circulation cerebral infarction without serious sequelae(mRS=0-2); Age from 18 to 80 years old; National Institute of Health stroke scale(NIHSS) from 6 to 25; Have provided signed written informed consent from the patient or the patient's legal representative. Exclusion Criteria: Brain CT shows cerebral hemorrhage disease: cerebral hemorrhage, subarachnoid hemorrhage, etc. Transient ischemic attack(TIA); Serious disturbance of consciousness: Glasgow Coma ScaleGCS（GCS）≤8; Combined angiotensin-converting enzyme inhibitor(ACEI) less than 5 half-time(according to its instruction), or need to be treated with ACEI; Cases treated with thrombolysis / stent surgery or expected to be treated with thrombolysis / interventional therapy / stent surgery. subjects with bleeding disorders at Past or present, laboratory tests: INR > 1.5 or APTT > 2 times; subjects with abnormal liver function (ALT/AST > 1.5 * ULN) and abnormal renal function (Cr> normal upper limit); subjects with history of epilepsy or other serious systemic disease before onset of AIS refused by PI to enroll ; subjects with cardiogenic stroke or cardiogenic stroke related high-risk factors identified by PI, such as atrial fibrillation, echocardiography or Mural thrombus etc; subjects diagnosised any malignancy (except basal cell carcinoma) within 5 years prior to the start of the study; subjects with severe dementia or can't cooperate to evaluate identified by PI; 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 subjects be allergic or intolerant to kallikrein at past; subjects be pregnant/lactating or possibly and planned pregnant; subjects be unsuitable for this clinical study identified by PI.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liying Cui, Doctor

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

NO.2 Hospital XiaMen

City

Xiamen

State/Province

Fujian

ZIP/Postal Code

361000

Country

China

Facility Name

HanDan Central Hospital

City

Handan

State/Province

Hebei

ZIP/Postal Code

056001

Country

China

Facility Name

Harrison International Peace Hospital

City

Hengshui

State/Province

Hebei

ZIP/Postal Code

053000

Country

China

Facility Name

Chenzhou NO.1 People's Hospital

City

Chenzhou

State/Province

Hunan

ZIP/Postal Code

423000

Country

China

Facility Name

Affiliated Hospital of Jiangsu University

City

Zhenjiang

State/Province

Jiangsu

ZIP/Postal Code

212000

Country

China

Facility Name

The Fourth Affiliated hospital of Zhejiang University School of Medicine

City

Yiwu

State/Province

Zhejiang

ZIP/Postal Code

322000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

28265861

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.

Results Reference

derived

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

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