Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease
NCT00911495
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Adult Trials: 18+ Years
- Age 18 to 45 years
- Established diagnosis of SCD-SS or SCD-SB0-thal
- At medical baseline, with no evidence of worsening of disease over the last 3 months
- Available and agree to return for follow-up visits for the full duration of the study
- Able to cooperate with study procedures
- Documented and observed written informed consent
- Vaso-occlusive crisis
- Recent major surgery, hospitalization, infection, significant bleeding,
cerebrovascular accident or seizure, or transfusion
- Currently receiving, or has received within the previous 4 weeks, any other
investigational agent
- Pregnant or lactating female; or female of childbearing age unable or unwilling to
comply with birth control or abstinence during the course of the study
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease | |||
| Official Title ICMJE | Phase 1/Phase 2 Study of the Safety, Pharmacokinetics, and Microvascular Effect of Titrating Doses of Intravenous GMI-1070, a Pan-Selectin Inhibitor, in Adults With Sickle Cell Disease | |||
| Brief Summary | 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 Phase 2 | |||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Sickle Cell Disease | |||
| Intervention ICMJE | Drug: GMI-1070
Intravenous GMI-1070 given as two doses over the course of one day | |||
| Study Arms ICMJE | Experimental: GMI-1070
Intervention: Drug: GMI-1070 | |||
| Publications * | 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. Erratum in: PLoS One. 2014;9(10):e111690. | |||
* 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 | Completed | |||
| Actual Enrollment ICMJE | 15 | |||
| Original Estimated Enrollment ICMJE | 20 | |||
| Actual Study Completion Date ICMJE | September 2010 | |||
| Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 45 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00911495 | |||
| Other Study ID Numbers ICMJE | GMI-1070-103 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | GlycoMimetics Incorporated | |||
| Study Sponsor ICMJE | GlycoMimetics Incorporated | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | GlycoMimetics Incorporated | |||
| Verification Date | May 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||