Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT01104467
Status:
COMPLETED
Last Update Posted:
2021-08-31
First Post:
2010-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C069588', 'term': 'salivary plasminogen activator alpha 1, Desmodus rotundus'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-30', 'studyFirstSubmitDate': '2010-04-08', 'studyFirstSubmitQcDate': '2010-04-13', 'lastUpdatePostDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety and tolerability of desmoteplase doses of 70 µg/kg and 90 µg/kg in Japanese patients with acute ischemic stroke as measured by the presence of symptomatic intracranial haemorrhage (sICH) within 72 hours after IMP', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'To evaluate the clinical improvement at Day 90 after administration of Investigational Medicinal Product (IMP) as measured by modified Rankin Scale (mRS)', 'timeFrame': '90 days'}, {'measure': 'To evaluate the clinical improvement at Day 7 and 30 after administration of IMP as measured by modified Rankin Scale (mRS)', 'timeFrame': 'Day 7 and Day 30'}, {'measure': 'To evaluate recanalisation at 18±6 hr after administration of IMP', 'timeFrame': '18±6 hr after administration of IMP'}, {'measure': 'To evaluate change in infarct size at 18±6 hr relative to pre-treatment infarct size', 'timeFrame': '18±6 hr after administration'}, {'measure': 'To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of desmoteplase', 'timeFrame': '0.5 - 9 hr'}, {'measure': 'To evaluate the immunogenicity of desmoteplase', 'timeFrame': 'Day 7, Day 30, Day 90'}, {'measure': 'To explore the predictive value of different volumes of absolute mismatch for the clinical response and other objectives', 'timeFrame': 'Day 90'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute Ischemic Stroke', 'Desmoteplase', 'Japan', 'Safety', 'Stroke', 'Tolerability'], 'conditions': ['Acute Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '26251244', 'type': 'DERIVED', 'citation': 'Mori E, Minematsu K, Nakagawara J, Hasegawa Y, Nagahiro S, Okada Y, Truelsen T, Lindsten A, Ogawa A, Yamaguchi T; DIAS-J Investigators. Safety and Tolerability of Desmoteplase Within 3 to 9 Hours After Symptoms Onset in Japanese Patients With Ischemic Stroke. Stroke. 2015 Sep;46(9):2549-54. doi: 10.1161/STROKEAHA.115.009917. Epub 2015 Aug 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate whether desmoteplase is safe and tolerated when given to Japanese patients with acute ischemic stroke', 'detailedDescription': 'The study is a safety and tolerability study of desmoteplase in Japanese patients with acute ischemic stroke. The study will test two doses'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of acute ischemic stroke\n* Provided Informed Consent\n* Male or female\n* Aged between 20 and 85 years inclusive\n* Treatment within 3-9 hr after onset of stroke symptoms.\n* NIHSS score of 4-24 inclusive with clinical signs of hemispheric infarction\n* Must receive IMP within 60 minutes after brain imaging\n* Cerebral artery occlusion or high-grade stenosis in MCA\n\nExclusion Criteria:\n\n* Pre-stroke mRS score of \\>1\n* Previously exposed to desmoteplase\n* Scores \\>2 on NIHSS question 1a indicating coma\n* History or clinical presentation of ICH, subarachnoid haemorrhage (SAH), arterio-venous malformation (AVM), moyamoya disease, cerebral neoplasm or aneurysm\n* Current use of oral anticoagulants and a prolonged prothrombin time (INR \\>1.6)\n* Treated with heparin in the previous 48 hours and has a prolonged partial thromboplastin time\n* Baseline platelet count \\<100,000/mm3\n* Baseline haematocrit of \\<0.25\n* Baseline blood glucose \\<50 mg/dl or \\>200 mg/dl\n* Uncontrolled hypertension defined by a blood pressure, systolic \\>185 mmHg or diastolic \\>110 mmHg on at least 2 separate occasions at least 10 minutes apart\n* Patient has hereditary or acquired hemorrhagic diathesis\n* Gastrointestinal or urinary bleeding within the past 21 days\n* Arterial puncture in a non-compressible site within the previous 7 days\n* Another stroke or a serious head injury in the past 6 weeks\n* Major surgery or serious injury, including other sites than the head, within the preceding 14 days\n* Seizure at the onset of stroke\n* Acute myocardial infarction (AMI) within the previous 3 weeks\n* Thrombolytic within the previous 72 hr\n* Pregnant\n\nOther inclusion and exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01104467', 'acronym': 'DIAS-J', 'briefTitle': 'Clinical Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lundbeck Japan K. K.'}, 'officialTitle': 'Randomised, Double-blind, Placebo-controlled, Dose-escalation Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': '11764A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desmoteplase 70 µg/kg', 'interventionNames': ['Drug: Desmoteplase']}, {'type': 'EXPERIMENTAL', 'label': 'Desmoteplase 90 µg/kg', 'interventionNames': ['Drug: Desmoteplase']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Desmoteplase', 'type': 'DRUG', 'description': '1 bolus injection of desmoteplase 70 µg/kg intravenous (IV)', 'armGroupLabels': ['Desmoteplase 70 µg/kg']}, {'name': 'Desmoteplase', 'type': 'DRUG', 'description': '1 bolus injection of desmoteplase 90 µg/kg (IV)', 'armGroupLabels': ['Desmoteplase 90 µg/kg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '1 bolus injection of placebo IV', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '010-0874', 'city': 'Akita', 'country': 'Japan', 'facility': 'JP006', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'zip': '810-8563', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'JP021', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '734-8551', 'city': 'Hiroshima', 'country': 'Japan', 'facility': 'JP018', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '374-0006', 'city': 'Isesaki', 'country': 'Japan', 'facility': 'JP007', 'geoPoint': {'lat': 36.31667, 'lon': 139.2}}, {'zip': '892-0853', 'city': 'Kagoshima', 'country': 'Japan', 'facility': 'JP024', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '216-8511', 'city': 'Kawasaki', 'country': 'Japan', 'facility': 'JP011', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'zip': '650-0046', 'city': 'Kobe', 'country': 'Japan', 'facility': 'JP015', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '861-4193', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'JP022', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '466-8650', 'city': 'Nagoya', 'country': 'Japan', 'facility': 'JP012', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '662-0934', 'city': 'Nishinomiya', 'country': 'Japan', 'facility': 'JP026', 'geoPoint': {'lat': 34.71562, 'lon': 135.33199}}, {'zip': '701-0192', 'city': 'Okayama', 'country': 'Japan', 'facility': 'JPO17', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '060-8570', 'city': 'Sapporo', 'country': 'Japan', 'facility': 'JP001', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '006-8555', 'city': 'Sapporo,Hokkaido', 'country': 'Japan', 'facility': 'JP002', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '982-0012', 'city': 'Sendai', 'country': 'Japan', 'facility': 'JP004', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '989-1253', 'city': 'Shibata', 'country': 'Japan', 'facility': 'JP005', 'geoPoint': {'lat': 37.95, 'lon': 139.33333}}, {'zip': '565-8565', 'city': 'Suita', 'country': 'Japan', 'facility': 'JP014', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '770-8503', 'city': 'Tokushima', 'country': 'Japan', 'facility': 'JP020', 'geoPoint': {'lat': 34.06667, 'lon': 134.56667}}, {'zip': '145-0065', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'JP009', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '471-8513', 'city': 'Toyota', 'country': 'Japan', 'facility': 'JP013', 'geoPoint': {'lat': 35.08333, 'lon': 137.15}}], 'overallOfficials': [{'name': 'Email contact via H. Lundbeck A/S', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LundbeckClinicalTrials@lundbeck.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lundbeck Japan K. K.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}