Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage
NCT02687191
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- ICH as documented by CT scan within 6.0 hours of symptom onset
- Baseline ICH volume > 5mL and < 60 mL
- Deep coma (Glasgow Coma Scale < 6)
- Modified Rankin Score > 3 prior to ICH onset
- Known history of schemic, vaso-occlusive or thrombotic events within 6 months prior to
screening
- Known prothrombotic disorders
- Known secondary ICH related to aneurysm, arteriovenous malformation, subarachnoid
hemorrhage, trauma, or other causes. CT angiography, MR, or other diagnostic studies
obtained as part of the standard of care may be used to assess eligibility.
- Known use of oral anticoagulant(s)
- Known use of low-molecular weight heparin or heparin
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| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title ICMJE | Safety and Tolerability of PF-05230907 in Intracerebral Hemorrhage | ||||
| Official Title ICMJE | A PHASE 1B MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY AND DETERMINE THE MAXIMUM TOLERATED DOSE OF PF-05230907 IN SUBJECTS WITH INTRACEREBRAL HEMORRHAGE (ICH) | ||||
| Brief Summary | This study employs a modified continual reassessment method (mCRM) design to estimate the maximum tolerated dose (MTD) of PF-05230907, defined as a target toxicity rate of 15% based on treatment emergent thromboembolic and/or ischemic events (TIEs). The mCRM design utilizes Bayesian methodology to continuously learn the dose-toxicity relationship, which is characterized by a parametric model. Subjects with a diagnosis of ICH (determined by computed tomography) will be enrolled in cohorts of 3. The total length of time planned for study participation is approximately 3 months; 6.0 hours for screening, a single dose administration with a 4-day minimum hospital confinement period and follow-up visits through Day 91. Severity of adverse events (AEs) and serious adverse events (SAEs) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. All subjects who receive PF-05230907 are evaluable for TIEs. The determination of MTD using mCRM modeling will be based on TIEs which occur through 7 days post-dose (Day 8). | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||
| Condition ICMJE | Intracerebral Hemorrhage | ||||
| Intervention ICMJE | Biological: PF-05230907
PF-05230907 IV bolus injection | ||||
| Study Arms ICMJE |
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| Publications * | Silva Blas Y, Diringer MN, Lo B, Masjuan J, Pérez de la Ossa N, Cardinal M, Yong F, Zhu T, Li G, Arkin S. Phase 1b Study to Evaluate Safety, Tolerability, and Maximum Tolerated Dose of PF-05230907 for Intracerebral Hemorrhage. Stroke. 2021 Jan;52(1):294-298. doi: 10.1161/STROKEAHA.120.029789. Epub 2020 Dec 4. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Actual Enrollment ICMJE | 21 | ||||
| Original Estimated Enrollment ICMJE | 50 | ||||
| Actual Study Completion Date ICMJE | January 2018 | ||||
| Actual Primary Completion Date | January 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 79 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Canada, Spain, United Kingdom, United States | ||||
| Removed Location Countries | Germany, Sweden | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT02687191 | ||||
| Other Study ID Numbers ICMJE | B2341002 2015-005703-83 ( EudraCT Number ) | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | April 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||