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Cerebral InfarctionPhase 4NCT02562183

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

A Phase 4 study testing kallikrein in people with Cerebral Infarction, run by Techpool Bio-Pharma Co., Ltd. at 7 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cerebral Infarction
What is being tested?
kallikrein
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,186 participants
Where
7 sitesChina
Study dates
Aug 2015to 30 Nov 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Chenzhou NO.1 People's Hospital

    Chenzhou, Hunan, 423000

  • HanDan Central Hospital

    Handan, Hebei, 056001

  • Harrison International Peace Hospital

    Hengshui, Hebei, 053000

  • NO.2 Hospital XiaMen

    Xiamen, Fujian, 361000

  • The Fourth Affiliated hospital of Zhejiang University School of Medicine

    Yiwu, Zhejiang, 322000

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212000

Other trials in China

About this study

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

Being tested
kallikrein
Medical subject headings
Cerebral Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • kallikreinDrug

    Also called KLK, Human urinary kallikrein

    Using kallikrein

Study groups in NCT02562183
Study groupRoleWhat they receive
kallikrein groupExperimentalSubjects receive kallikrein treatment according to real clinical practice (suggest above 14days treatment),0.15 peptide nucleic acids(PNA), once a day.
Receives: Drug: kallikrein

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse Events

    Measured: From enrolled to the day 90

Secondary outcomes (6)

  1. Cerebral infarction on the National Institute of Health stroke scale

    Measured: The day 8,15 and 22 after enrolled

  2. Recurrence rate of acute cerebral infarction

    Measured: From enrolled to the day 90

  3. Activities of daily living on the Barthel Index

    Measured: The day 15,22 and 90 after enrolled

  4. Patients body status on the Modified Rankin Scale

    Measured: The day 15, 22 and 90 after enrolled

  5. EQ-5D-3L score

    Measured: The day 15, 22 and 90 after enrolled

  6. Evaluation of pharmaceutical economics

    Measured: The day 15, 22 and 90 after enrolled

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2015 (estimated)
  2. Study startAug 2015
  3. Primary completion30 Nov 2018 (estimated)
  4. Study completion30 Nov 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,186 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02562183
Sponsor's protocol ID
KLK-4002
Status last verified
Jan 2018
First submitted
10 Sep 2015
Last updated
17 Jan 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 28265861

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing kallikrein in people with Cerebral Infarction, run by Techpool Bio-Pharma Co., Ltd. at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (time frame: From enrolled to the day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02562183, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.

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