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This Phase 1/Phase 2 study will evaluate GMI-1070, a pan-selectin inhibitor, in adults with stable sickle cell disease. The study will assess safety, pharmacokinetics, and microvascular effects of intravenous GMI-1070 in the outpatient setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GMI-1070 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GMI-1070 | Drug | Intravenous GMI-1070 given as two doses over the course of one day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety as Measured by the Number of Participants With Adverse Events | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total Plasma Clearance | 48 hours | |
| Volume of the Central Compartment | 48 hours | |
| Intercompartmental Clearance |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Flow and Biomarkers of Adhesion | As an exploratory outcome mean change in microvascular blood flow from baseline to each time point was measured. Microvascular blood flow was also measured as microFI, perfused vessel density, and RBC velocity. | 48 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen Thackray, MD | GlycoMimetics Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital & Research Center Oakland | Oakland | California | 94609 | United States | ||
| University of California at Davis, CCRC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24988449 | Derived | Wun T, Styles L, DeCastro L, Telen MJ, Kuypers F, Cheung A, Kramer W, Flanner H, Rhee S, Magnani JL, Thackray H. Phase 1 study of the E-selectin inhibitor GMI 1070 in patients with sickle cell anemia. PLoS One. 2014 Jul 2;9(7):e101301. doi: 10.1371/journal.pone.0101301. eCollection 2014. |
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First subject enrolled 28 May 2009; last subject completed 6 July 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | GMI-1070 | GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GMI-1070 | GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety as Measured by the Number of Participants With Adverse Events | All enrolled subjects were analyzed for safety. | Posted | Number | participants | 28 days |
|
|
28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GMI-1070 | GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 18007181021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C553182 | rivipansel |
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| 48 hours |
| Volume of the Peripheral Compartment | 48 hours |
| Sacramento |
| California |
| 95817 |
| United States |
| Duke Comprehensive Sickle Cell Center | Durham | North Carolina | 27710 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Total Plasma Clearance | All subjects were analyzed for pharmacokinetics; one subject of the 15 enrolled was lost to follow-up. | Posted | Mean | Standard Deviation | mL/h/kg | 48 hours |
|
|
|
| Other Pre-specified | Blood Flow and Biomarkers of Adhesion | As an exploratory outcome mean change in microvascular blood flow from baseline to each time point was measured. Microvascular blood flow was also measured as microFI, perfused vessel density, and RBC velocity. | Not Posted | 48 hours | Participants |
| Secondary | Volume of the Central Compartment | Posted | Mean | Standard Deviation | mL/kg | 48 hours |
|
|
|
| Secondary | Intercompartmental Clearance | Posted | Mean | Standard Deviation | mL/h/kg | 48 hours |
|
|
|
| Secondary | Volume of the Peripheral Compartment | Posted | Mean | Standard Deviation | mL/kg | 48 hours |
|
|
|
| 0 |
| 15 |
| 9 |
| 15 |
| Anemia | Blood and lymphatic system disorders |
|
| Leukocytosis | Blood and lymphatic system disorders |
|
| sickle cell anemia with crisis | Congenital, familial and genetic disorders |
|
| vomiting | Gastrointestinal disorders |
|
| infusion site pain | General disorders |
|
| hypokalemia | Metabolism and nutrition disorders |
|
| arthralgia | Musculoskeletal and connective tissue disorders |
|
| cough | Respiratory, thoracic and mediastinal disorders |
|
| oropharyngeal pain | Respiratory, thoracic and mediastinal disorders |
|
| pruritus | Skin and subcutaneous tissue disorders |
|
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| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |