Safety Evaluation of 3K3A-APC in Ischemic Stroke "RHAPSODY"

Active, not recruiting

Phase 2 Results N/A

Update History

12 Apr '17
The description was updated.
New
This is a multicenter, prospective, randomized, controlled, double-blinded Phase 2 study intended to evaluate the safety, PK and preliminary efficacy of 3K3A-APC following treatment with tPA, mechanical thrombectomy or both in subjects with moderate to severe acute ischemic stroke. Approximately 115 subjects will be randomized, which includes the planned 88 subjects in groups of four to either 3K3A-APC or placebo (in a 3:1 ratio) and the additional placebo subjects who will be enrolled during safety review pauses. This study will utilize a modified version of the continual reassessment method (CRM) in order to establish a maximum tolerated dose (MTD). Eligible subjects will receive 3K3A-APC or placebo every 12 hours for up to 5 doses (approximately 3 days), or until discharge from the hospital, whichever occurs first. Subjects will be monitored for safety evaluations through Day 7 (or discharge, if earlier) and are expected to be seen on Day 7, 14, 30 and 90 for safety and outcome evaluations.
Old
This is a multicenter, prospective, randomized, controlled, double-blinded Phase 2 study intended to evaluate the safety, PK and preliminary efficacy of 3K3A-APC following treatment with tPA, mechanical thrombectomy or both in subjects with moderate to severe acute ischemic stroke. Approximately 100 subjects will be randomized, which includes the planned 88 subjects in groups of four to either 3K3A-APC or placebo (in a 3:1 ratio) and the additional placebo subjects who will be enrolled during safety review pauses. This study will utilize a modified version of the continual reassessment method (CRM) in order to establish a maximum tolerated dose (MTD). Eligible subjects will receive 3K3A-APC or placebo every 12 hours for up to 5 doses (approximately 3 days), or until discharge from the hospital, whichever occurs first. Subjects will be monitored for safety evaluations through Day 7 (or discharge, if earlier) and are expected to be seen on Day 7, 14, 30 and 90 for safety and outcome evaluations.
The gender criteria for eligibility was updated to "All."
A location was updated in Los Angeles.
New
The overall status was removed for Stroke Center.
A location was updated in Chicago.
New
The overall status was removed for Stroke Center.
A location was updated in Kansas City.
New
The overall status was removed for Stroke Center.
A location was updated in Boston.
New
The overall status was removed for Stroke Center.
A location was updated in St. Louis.
New
The overall status was removed for Stroke Center.
A location was updated in Buffalo.
New
The overall status was removed for Stroke Center.
A location was updated in New York.
New
The overall status was removed for Stroke Center.
A location was updated in Rochester.
New
The overall status was removed for Stroke Center.
A location was updated in Cincinnati.
New
The overall status was removed for Stroke Center.
A location was updated in Columbus.
New
The overall status was removed for Stroke Center.
A location was updated in Pittsburgh.
New
The overall status was removed for Stroke Center.
A location was updated in Nashville.
New
The overall status was removed for Stroke Center.
A location was updated in Dallas.
New
The overall status was removed for Stroke Center.
A location was updated in Salt Lake City.
New
The overall status was removed for Stroke Center.
A location was updated in Charlottesville.
New
The overall status was removed for Stroke Center.
13 Jul '16
A location was updated in Chicago.
New
The overall status was removed for Stroke Center.
A location was updated in Nashville.
New
The overall status was removed for Stroke Center.
A location was updated in Dallas.
New
The overall status was removed for Stroke Center.
23 Jun '15
The Summary of Purpose was updated.
New
The purpose of this study is to evaluate the safety, pharmacokinetics (PK) and preliminary efficacy of multiple ascending intravenous doses of 3K3A-APC, a Recombinant Variant of Human activated protein C (APC), in in the treatment of acute ischemic stroke following treatment with recombinant tissue plasminogen activator (tPA), mechanical thrombectomy or both.
Old
The purpose of this study is to evaluate the safety, pharmacokinetics (PK) and preliminary efficacy of multiple ascending intravenous doses of 3K3A-APC, a Recombinant Variant of Human activated protein C (APC), in in the treatment of acute ischemic stroke following treatment with recombinant tissue plasminogen activator (tPA).
The description was updated.
New
This is a multicenter, prospective, randomized, controlled, double-blinded Phase 2 study intended to evaluate the safety, PK and preliminary efficacy of 3K3A-APC following treatment with tPA, mechanical thrombectomy or both in subjects with moderate to severe acute ischemic stroke. Approximately 100 subjects will be randomized, which includes the planned 88 subjects in groups of four to either 3K3A-APC or placebo (in a 3:1 ratio) and the additional placebo subjects who will be enrolled during safety review pauses. This study will utilize a modified version of the continual reassessment method (CRM) in order to establish a maximum tolerated dose (MTD). Eligible subjects will receive 3K3A-APC or placebo every 12 hours for up to 5 doses (approximately 3 days), or until discharge from the hospital, whichever occurs first. Subjects will be monitored for safety evaluations through Day 7 (or discharge, if earlier) and are expected to be seen on Day 7, 14, 30 and 90 for safety and outcome evaluations.
Old
This is a multicenter, prospective, randomized, controlled, double-blinded Phase 2 study intended to evaluate the safety, PK and preliminary efficacy of 3K3A-APC following administration of tPA in subjects with moderately severe acute ischemic stroke. Approximately 100 subjects will be randomized, which includes the planned 88 subjects in groups of four to either 3K3A-APC or placebo (in a 3:1 ratio) and the additional placebo subjects who will be enrolled during safety review pauses. This study will utilize a modified version of the continual reassessment method (CRM) in order to establish a maximum tolerated dose (MTD). Eligible subjects will receive 3K3A-APC or placebo every 12 hours for up to 5 doses (approximately 3 days), or until discharge from the hospital, whichever occurs first. Subjects will be monitored for safety evaluations through Day 7 (or discharge, if earlier) and are expected to be seen on Day 7, 14, 30 and 90 for safety and outcome evaluations.
The eligibility criteria were updated.
New
Inclusion Criteria: - Acute ischemic stroke - Able to receive IV tPA, mechanical thrombectomy or both - National Institutes of Health Stroke Scale (NIHSS) score of ≥ 5 - Signed informed consent - Mechanical thrombectomy subjects only: onset time to arterial puncture time < 6 hours Exclusion Criteria: - History of stroke or penetrating head injury within 90 days prior to enrollment - History of previous or current diagnosis of intracranial hemorrhage that represents a potential for re-hemorrhage if subjected to thrombolytic therapy or mechanical thrombectomy - Moyamoya disease, cerebral arterio-venous malformation (AVM), known unsecured aneurysm requiring intervention during the acute study period - Presence of other neurological or non-neurological co-morbidities that may lead, independently of the current stroke, to further deterioration in the subject's neurological status during the trial period - Presence of premorbid neurological deficits and functional limitations assessed by a retrospective Modified Rankin Scale (mRS) score of ≥ 2 - Mechanical thrombectomy subjects only: baseline non-contrast CT scan revealing a large core occlusion as defined by local protocol - Prolonged prothrombin time (PT) or aPTT - Severe hypertension or hypotension - Glomerular filtration rate (GFR) <35 mL/min - Blood glucose concentration < 50 mg/dL - Prior exposure to any exogenous form of APC
Old
Inclusion Criteria: - Acute hemispheric ischemic stroke - Able to receive IV tPA - National Institutes of Health Stroke Scale (NIHSS) score of 7 to 20 - Signed informed consent Exclusion Criteria: - History of stroke or penetrating head injury within 90 days prior to enrollment - History of previous or current diagnosis of intracranial hemorrhage, moyamoya disease, cerebral arterio-venous malformation (AVM), known unsecured aneurysm, or intracranial neoplasm - Presence of other neurological or non-neurological co-morbidities that may lead, independently of the current stroke, to further deterioration in the subject's neurological status during the trial period - Presence of premorbid neurological deficits and functional limitations assessed by a retrospective Modified Rankin Scale (mRS) score of ≥ 2 - Use of oral anticoagulants or heparin within 48 hours - Prolonged prothrombin time (PT) or aPTT - Gastrointestinal, respiratory or urinary tract hemorrhage within 30 days prior to enrollment - Severe hypertension or hypotension - Glomerular filtration rate (GFR) <35 mL/min - Platelet count < 75,000/mm3 - Blood glucose concentration < 50 mg/dL - Prior exposure to any exogenous form of APC
23 May '15
A location was updated in Charlottesville.
New
The overall status was removed for Stroke Center.
2 May '15
A location was updated in Rochester.
New
The overall status was removed for Stroke Center.
3 Mar '15
A location was updated in Dallas.
New
The overall status was removed for Stroke Center.
1 Jan '15
A location was updated in New York.
New
The overall status was removed for Stroke Center.
A location was updated in Cincinnati.
New
The overall status was removed for Stroke Center.
16 Dec '14
The description was updated.
New
This is a multicenter, prospective, randomized, controlled, double-blinded Phase 2 study intended to evaluate the safety, PK and preliminary efficacy of 3K3A-APC following administration of tPA in subjects with moderately severe acute ischemic stroke. Approximately 100 subjects will be randomized, which includes the planned 88 subjects in groups of four to either 3K3A-APC or placebo (in a 3:1 ratio) and the additional placebo subjects who will be enrolled during safety review pauses. This study will utilize a modified version of the continual reassessment method (CRM) in order to establish a maximum tolerated dose (MTD). Eligible subjects will receive 3K3A-APC or placebo every 12 hours for up to 5 doses (approximately 3 days), or until discharge from the hospital, whichever occurs first. Subjects will be monitored for safety evaluations through Day 7 (or discharge, if earlier) and are expected to be seen on Day 7, 14, 30 and 90 for safety and outcome evaluations.
Old
This is a multicenter, prospective, randomized, controlled, double-blinded Phase 2 study intended to evaluate the safety, PK and preliminary efficacy of 3K3A-APC following administration of tPA in subjects with moderately severe acute ischemic stroke. Approximately 100 subjects will be randomized, which includes the planned 88 subjects in groups of four to either 3K3A-APC or placebo (in a 3:1 ratio) and the additional placebo subjects who will be enrolled during safety review pauses. This study will utilize a modified version of the continual reassessment method (CRM) in order to establish a maximum tolerated dose (MTD). Eligible subjects will receive 3K3A-APC or placebo every 12 hours for up to 5 doses (approximately 3 days), or until discharge from the hospital, whichever occurs first. Subjects will be monitored for safety evaluations through Day 7 (or discharge, if earlier) and are expected to be seen on Day 7, 30 and 90 for safety and outcome evaluations.
A location was updated in Chicago.
New
The overall status was removed for Stroke Center.
25 Nov '14
A location was updated in Columbus.
New
The overall status was removed for Stroke Center.
18 Nov '14
A location was updated in Salt Lake City.
New
The overall status was removed for Stroke Center.
11 Nov '14
A location was updated in Boston.
New
The overall status was removed for Stroke Center.
30 Oct '14
A location was updated in St. Louis.
New
The overall status was removed for Stroke Center.
A location was updated in Kansas City.
New
The overall status was removed for Stroke Center.
A location was updated in Nashville.
New
The overall status was removed for Stroke Center.
24 Oct '14
A location was updated in Buffalo.
New
The overall status was removed for Stroke Center.
22 Oct '14
A location was updated in Los Angeles.
New
The overall status was removed for Stroke Center.