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A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients

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: NCT01014975
Recruitment Status : Completed
First Posted : November 17, 2009
Results First Posted : October 21, 2015
Last Update Posted : October 21, 2015
Sponsor:
Information provided by (Responsible Party):
Grifols Therapeutics LLC

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Ischemic Stroke
Intervention Biological: Plasmin (Human)
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 20 mg Plasmin (Human) 40 mg Plasmin (Human) 80 mg Plasmin (Human)
Hide Arm/Group Description

20 mg of Plasmin (Human)

Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus

40 mg of Plasmin (Human)

Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus

80 mg of Plasmin (Human)

Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus

Period Title: Overall Study
Started 8 16 16
Completed 4 13 10
Not Completed 4 3 6
Reason Not Completed
Withdrawal by Subject             1             0             1
Death             3             3             4
Lost to Follow-up             0             0             1
Arm/Group Title Safety Population
Hide Arm/Group Description Plasmin (Human): Plasmin (Human), 20 mg, 40 mg, or 80 mg, delivered through a catheter into a thrombus
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
Safety population includes all subject who received any amount of Plasmin.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  20.0%
>=65 years
32
  80.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants
73.1  (9.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
20
  50.0%
Male
20
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants
Serbia 10
France 7
Slovakia 5
Spain 8
Austria 1
Australia 5
Germany 4
1.Primary Outcome
Title Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title 20 mg Plasmin (Human) 40 mg Plasmin (Human) 80 mg Plasmin (Human)
Hide Arm/Group Description:

20 mg of Plasmin (Human)

Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus

40 mg of Plasmin (Human)

Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus

80 mg of Plasmin (Human)

Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus

Overall Number of Participants Analyzed 8 16 16
Measure Type: Number
Unit of Measure: participants
0 0 0
Time Frame Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment.
Adverse Event Reporting Description Treatment-emergent adverse events were adverse events reported after the subject received study medication.
 
Arm/Group Title 20 mg Plasmin (Human) 40 mg Plasmin (Human) 80 mg Plasmin (Human)
Hide Arm/Group Description

20 mg of Plasmin (Human)

Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus

40 mg of Plasmin (Human)

Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus

80 mg of Plasmin (Human)

Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus

All-Cause Mortality
20 mg Plasmin (Human) 40 mg Plasmin (Human) 80 mg Plasmin (Human)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
20 mg Plasmin (Human) 40 mg Plasmin (Human) 80 mg Plasmin (Human)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/8 (75.00%)   7/16 (43.75%)   7/16 (43.75%) 
Cardiac disorders       
Cardiac arrest  1  0/8 (0.00%)  2/16 (12.50%)  1/16 (6.25%) 
Cardiac failure  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
Gastrointestinal disorders       
Duodenal ulcer haemorrhage  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
Faecaloma  1  0/8 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Gastric ulcer haemorrhage  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
Gastrointestinal haemorrhage  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Haematemesis  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Melaena  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Injury, poisoning and procedural complications       
Vascular pseudoaneurysm  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Nervous system disorders       
Brain oedema  1  1/8 (12.50%)  1/16 (6.25%)  0/16 (0.00%) 
Cerebral infarction  1  1/8 (12.50%)  1/16 (6.25%)  0/16 (0.00%) 
Cerebrovascular accident  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
Haemorrhagic cerebral infarction  1  0/8 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Psychiatric disorders       
Delirium  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pneumonia aspiration  1  1/8 (12.50%)  0/16 (0.00%)  1/16 (6.25%) 
Pulmonary oedema  1  0/8 (0.00%)  0/16 (0.00%)  2/16 (12.50%) 
Aspiration  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
Bronchial obstruction  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Bronchospasm  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
Pulmonary embolism  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
Vascular disorders       
Cardiopulmonary failure  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Arterial thrombosis limb  1  0/8 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
20 mg Plasmin (Human) 40 mg Plasmin (Human) 80 mg Plasmin (Human)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   12/16 (75.00%)   12/16 (75.00%) 
Blood and lymphatic system disorders       
ANAEMIA  1  1/8 (12.50%)  2/16 (12.50%)  1/16 (6.25%) 
Cardiac disorders       
ATRIAL FIBRILLATION  1  1/8 (12.50%)  2/16 (12.50%)  1/16 (6.25%) 
BRADYCARDIA  1  0/8 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
CARDIAC FAILURE  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
TACHYCARDIA  1  0/8 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
VENTRICULAR TACHYCARDIA  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
Gastrointestinal disorders       
CONSTIPATION  1  5/8 (62.50%)  1/16 (6.25%)  1/16 (6.25%) 
NAUSEA  1  2/8 (25.00%)  0/16 (0.00%)  2/16 (12.50%) 
DIARRHOEA  1  0/8 (0.00%)  2/16 (12.50%)  0/16 (0.00%) 
FAECAL INCONTINENCE  1  2/8 (25.00%)  0/16 (0.00%)  0/16 (0.00%) 
ABDOMINAL PAIN  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
HAEMATEMESIS  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
MELAENA  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
VOMITING  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
General disorders       
PYREXIA  1  3/8 (37.50%)  2/16 (12.50%)  5/16 (31.25%) 
OEDEMA PERIPHERAL  1  1/8 (12.50%)  2/16 (12.50%)  0/16 (0.00%) 
CHEST PAIN  1  1/8 (12.50%)  0/16 (0.00%)  1/16 (6.25%) 
DRUG INTOLERANCE  1  0/8 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Infections and infestations       
URINARY TRACT INFECTION  1  2/8 (25.00%)  1/16 (6.25%)  3/16 (18.75%) 
BRONCHITIS  1  1/8 (12.50%)  0/16 (0.00%)  1/16 (6.25%) 
ORAL CANDIDIASIS  1  2/8 (25.00%)  0/16 (0.00%)  0/16 (0.00%) 
ABSCESS ORAL  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
BACTERAEMIA  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
BACTERIAL INFECTION  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
CANDIDIASIS  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
FUNGAL SKIN INFECTION  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
INFECTION  1  0/8 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
KERATITIS HERPETIC  1  0/8 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
LOWER RESPIRATORY TRACT INFECTION  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
ORCHITIS  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
PNEUMONIA  1  0/8 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
RESPIRATORY TRACT INFECTION  1  0/8 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
SEPSIS  1  0/8 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Injury, poisoning and procedural complications       
EXCORIATION  1  2/8 (25.00%)  0/16 (0.00%)  0/16 (0.00%) 
Investigations       
INTERNATIONAL NORMALISED RATIO INCREASED  1  0/8 (0.00%)  1/16 (6.25%)  1/16 (6.25%) 
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
BLOOD GLUCOSE ABNORMAL  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
GAMMA-GLUTAMYLTRANSFERASE INCREASED  1  0/8 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
HEPATIC ENZYME INCREASED  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
Metabolism and nutrition disorders       
HYPOKALAEMIA  1  2/8 (25.00%)  3/16 (18.75%)  0/16 (0.00%) 
HYPERGLYCAEMIA  1  2/8 (25.00%)  1/16 (6.25%)  0/16 (0.00%) 
ANOREXIA  1  0/8 (0.00%)  2/16 (12.50%)  0/16 (0.00%) 
DIABETES MELLITUS  1  1/8 (12.50%)  0/16 (0.00%)  1/16 (6.25%) 
CEREBRAL SALT-WASTING SYNDROME  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
DEHYDRATION  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
HYPERKALAEMIA  1  0/8 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
HYPOALBUMINAEMIA  1  0/8 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
HYPOGLYCAEMIA  1  0/8 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
MALNUTRITION  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
Musculoskeletal and connective tissue disorders       
BACK PAIN  1  2/8 (25.00%)  1/16 (6.25%)  1/16 (6.25%) 
NECK PAIN  1  1/8 (12.50%)  1/16 (6.25%)  0/16 (0.00%) 
PAIN IN EXTREMITY  1  2/8 (25.00%)  0/16 (0.00%)  0/16 (0.00%) 
GROIN PAIN  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
MUSCULOSKELETAL PAIN  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
OSTEOARTHRITIS  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
RHEUMATOID ARTHRITIS  1  0/8 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Nervous system disorders       
HEADACHE  1  2/8 (25.00%)  2/16 (12.50%)  0/16 (0.00%) 
CEREBRAL HAEMORRHAGE  1  1/8 (12.50%)  1/16 (6.25%)  0/16 (0.00%) 
MUSCLE SPASTICITY  1  1/8 (12.50%)  0/16 (0.00%)  1/16 (6.25%) 
CENTRAL PAIN SYNDROME  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
CEREBRAL INFARCTION  1  0/8 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
COMPLEX REGIONAL PAIN SYNDROME  1  0/8 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
HAEMORRHAGE INTRACRANIAL  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
HAEMORRHAGIC CEREBRAL INFARCTION  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
HYPERTONIA  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
NEURALGIA  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
VASCULAR DEMENTIA  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
Psychiatric disorders       
DEPRESSION  1  1/8 (12.50%)  1/16 (6.25%)  1/16 (6.25%) 
INSOMNIA  1  2/8 (25.00%)  0/16 (0.00%)  1/16 (6.25%) 
ABNORMAL BEHAVIOUR  1  0/8 (0.00%)  2/16 (12.50%)  0/16 (0.00%) 
AGITATION  1  0/8 (0.00%)  1/16 (6.25%)  1/16 (6.25%) 
DYSSOMNIA  1  0/8 (0.00%)  0/16 (0.00%)  2/16 (12.50%) 
SLEEP DISORDER  1  1/8 (12.50%)  1/16 (6.25%)  0/16 (0.00%) 
CONFUSIONAL STATE  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
HALLUCINATION  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
Renal and urinary disorders       
URINARY INCONTINENCE  1  2/8 (25.00%)  0/16 (0.00%)  0/16 (0.00%) 
URINARY RETENTION  1  2/8 (25.00%)  0/16 (0.00%)  0/16 (0.00%) 
BLADDER DISTENSION  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
Reproductive system and breast disorders       
PROSTATITIS  1  0/8 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
EPISTAXIS  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
RESPIRATORY DISORDER  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
SLEEP APNOEA SYNDROME  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Skin and subcutaneous tissue disorders       
INTERTRIGO  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
SKIN ULCER  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Vascular disorders       
HYPERTENSION  1  1/8 (12.50%)  1/16 (6.25%)  2/16 (12.50%) 
HAEMATOMA  1  0/8 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
HYPOTENSION  1  1/8 (12.50%)  0/16 (0.00%)  0/16 (0.00%) 
PERIPHERAL ISCHAEMIA  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
PHLEBITIS  1  0/8 (0.00%)  1/16 (6.25%)  0/16 (0.00%) 
THROMBOPHLEBITIS  1  0/8 (0.00%)  0/16 (0.00%)  1/16 (6.25%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Site may publish results from the study, after providing sponsor 30 days' notice prior to submitting a manuscript or other materials related to the study to any outside party. At sponsor's request, site will remove any confidential information (other than study results), and site will upon sponsor's request delay publication or presentation for a period of up to 120 days to allow sponsor to protect its interests in any sponsor inventions.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Henry Li, PhD
Organization: Grifols Therapeutics, Inc.
Phone: 800-520-2807
EMail: henry.li@grifols.com
Layout table for additonal information
Responsible Party: Grifols Therapeutics LLC
ClinicalTrials.gov Identifier: NCT01014975    
Other Study ID Numbers: T05018-1001
2010-019760-36 ( EudraCT Number )
First Submitted: November 16, 2009
First Posted: November 17, 2009
Results First Submitted: August 20, 2015
Results First Posted: October 21, 2015
Last Update Posted: October 21, 2015