Phase 2
Completed N=15
Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease
Source: ClinicalTrials.gov NCT00911495 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
May 2013
Primary outcomePrimary: Safety as Measured by the Number of Participants With Adverse Events — 9 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety as Measured by the Number of Participants With Adverse Events |
9 | — |
| SECONDARY Total Plasma Clearance |
19.6 | — |
| SECONDARY Volume of the Central Compartment |
120 | — |
| SECONDARY Intercompartmental Clearance |
31.6 | — |
| SECONDARY Volume of the Peripheral Compartment |
64.2 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00911495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.