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Study of Intravenous GMI-1070 in Adults With Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT00911495
Recruitment Status : Completed
First Posted : June 2, 2009
Results First Posted : May 3, 2013
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sickle Cell Disease
Intervention Drug: GMI-1070
Enrollment 15
Recruitment Details First subject enrolled 28 May 2009; last subject completed 6 July 2010.
Pre-assignment Details  
Arm/Group Title GMI-1070
Hide Arm/Group Description GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
Period Title: Overall Study
Started 15
Completed 14
Not Completed 1
Arm/Group Title GMI-1070
Hide Arm/Group Description GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants
28
(19 to 50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
6
  40.0%
Male
9
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Safety as Measured by the Number of Participants With Adverse Events
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects were analyzed for safety.
Arm/Group Title GMI-1070
Hide Arm/Group Description:
GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
9
2.Secondary Outcome
Title Total Plasma Clearance
Hide Description [Not Specified]
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were analyzed for pharmacokinetics; one subject of the 15 enrolled was lost to follow-up.
Arm/Group Title GMI-1070
Hide Arm/Group Description:
GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: mL/h/kg
19.6  (6.42)
3.Secondary Outcome
Title Volume of the Central Compartment
Hide Description [Not Specified]
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GMI-1070
Hide Arm/Group Description:
GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: mL/kg
120  (30.7)
4.Secondary Outcome
Title Intercompartmental Clearance
Hide Description [Not Specified]
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GMI-1070
Hide Arm/Group Description:
GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: mL/h/kg
31.6  (17.2)
5.Secondary Outcome
Title Volume of the Peripheral Compartment
Hide Description [Not Specified]
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GMI-1070
Hide Arm/Group Description:
GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: mL/kg
64.2  (19.6)
6.Other Pre-specified Outcome
Title Blood Flow and Biomarkers of Adhesion
Hide Description 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.
Time Frame 48 hours
Outcome Measure Data Not Reported
Time Frame 28 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GMI-1070
Hide Arm/Group Description GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
All-Cause Mortality
GMI-1070
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
GMI-1070
Affected / at Risk (%)
Total   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GMI-1070
Affected / at Risk (%)
Total   9/15 (60.00%) 
Blood and lymphatic system disorders   
Anemia  1/15 (6.67%) 
Leukocytosis  1/15 (6.67%) 
Congenital, familial and genetic disorders   
sickle cell anemia with crisis  2/15 (13.33%) 
Gastrointestinal disorders   
vomiting  1/15 (6.67%) 
General disorders   
infusion site pain  1/15 (6.67%) 
Metabolism and nutrition disorders   
hypokalemia  1/15 (6.67%) 
Musculoskeletal and connective tissue disorders   
arthralgia  1/15 (6.67%) 
Nervous system disorders   
Headache  4/15 (26.67%) 
Respiratory, thoracic and mediastinal disorders   
cough  1/15 (6.67%) 
oropharyngeal pain  1/15 (6.67%) 
Skin and subcutaneous tissue disorders   
pruritus  1/15 (6.67%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer Inc.
Phone: 18007181021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00911495     History of Changes
Other Study ID Numbers: GMI-1070-103
First Submitted: May 27, 2009
First Posted: June 2, 2009
Results First Submitted: September 11, 2012
Results First Posted: May 3, 2013
Last Update Posted: September 23, 2016