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Reslizumab to Prevent Post-treatment Eosinophilia in Loiasis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT01111305
First received: April 24, 2010
Last updated: April 27, 2017
Last verified: November 2016
Results First Received: April 27, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Loiasis
Interventions: Drug: Reslizumab
Drug: Diethylcarbamazine
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Reslizumab

Reslizumab

Diethylcarbamazine

Placebo

Placebo

Diethylcarbamazine


Participant Flow:   Overall Study
    Reslizumab   Placebo
STARTED   4   4 
COMPLETED   4   4 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Reslizumab

Reslizumab

Diethylcarbamazine

Placebo

Placebo

Diethylcarbamazine

Total Total of all reporting groups

Baseline Measures
   Reslizumab   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   4   8 
Age 
[Units: Years]
Median (Full Range)
 36 
 (22 to 44) 
 29 
 (20 to 55) 
 31.5 
 (20 to 55) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1  25.0%      1  25.0%      2  25.0% 
Male      3  75.0%      3  75.0%      6  75.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      4 100.0%      4 100.0%      8 100.0% 
White      0   0.0%      0   0.0%      0   0.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   4   4   8 
Loa loa microfilarial level 
[Units: mf/mL]
Geometric Mean (Full Range)
 212 
 (0 to 2120) 
 357 
 (178 to 810) 
 275 
 (0 to 2120) 
Absolute eosinophil count 
[Units: Cells/microliter]
Geometric Mean (Full Range)
 1350 
 (530 to 3130) 
 710 
 (560 to 1590) 
 980 
 (530 to 3130) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Reduction in Peak Eosinophil Count Measure as a Percent of Baseline Count.   [ Time Frame: during the first 7 days of DEC treatment ]

2.  Secondary:   Frequency and Severity of AE's   [ Time Frame: 7 days following initiation of DEC treatment ]

3.  Secondary:   Proportion of Subjects Who Clear Blood Microfilariae   [ Time Frame: 3, 7, and 28 days after initiation of treatment with DEC ]

4.  Secondary:   Markers of Eosinophil Activation Including Levels of Eosinophil Surface Marker Expression and Serum Levels of Eosinophil Granule Proteins   [ Time Frame: 12/31/16 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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:  
Name/Title: Dr. Amy Klion
Organization: NIAID/NIH
phone: 301-435-8903
e-mail: aklion@niaid.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01111305     History of Changes
Other Study ID Numbers: 10-I-0101
Study First Received: April 24, 2010
Results First Received: April 27, 2017
Last Updated: April 27, 2017