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Reslizumab to Prevent Post-treatment Eosinophilia in Loiasis

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ClinicalTrials.gov Identifier: NCT01111305
Recruitment Status : Completed
First Posted : April 27, 2010
Results First Posted : June 1, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

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
Enrollment 31
Recruitment Details  
Pre-assignment Details 31 subjects were enrolled on the screening phase of this protocol, of which 13 had Loa loa infection. Of these 13, 3 were excluded for Loa loa microfilarial loads that were too high, 1 could not comply with the trial time points, and one was lost to followup. This left 8 subjects who were enrolled on the treatment portion of the study.
Arm/Group Title Reslizumab Placebo
Hide Arm/Group Description

Reslizumab

Diethylcarbamazine

Placebo

Diethylcarbamazine

Period Title: Overall Study
Started 4 4
Completed 4 4
Not Completed 0 0
Arm/Group Title Reslizumab Placebo Total
Hide Arm/Group Description

Reslizumab

Diethylcarbamazine

Placebo

Diethylcarbamazine

Total of all reporting groups
Overall Number of Baseline Participants 4 4 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 8 participants
36
(22 to 44)
29
(20 to 55)
31.5
(20 to 55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
Female
1
  25.0%
1
  25.0%
2
  25.0%
Male
3
  75.0%
3
  75.0%
6
  75.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 4 participants 8 participants
4 4 8
Loa loa microfilarial level  
Geometric Mean (Full Range)
Unit of measure:  mf/mL
Number Analyzed 4 participants 4 participants 8 participants
212
(0 to 2120)
357
(178 to 810)
275
(0 to 2120)
Absolute eosinophil count  
Geometric Mean (Full Range)
Unit of measure:  Cells/microliter
Number Analyzed 4 participants 4 participants 8 participants
1350
(530 to 3130)
710
(560 to 1590)
980
(530 to 3130)
1.Primary Outcome
Title Change in Peak Eosinophil Count Measure as a Percent of Baseline Count.
Hide Description Peak eosinophil count during the first 7 days of treatment as a percent of the baseline count
Time Frame during the first 7 days of DEC treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received diethylcarbamazine treatment
Arm/Group Title Reslizumab + DEC Placebo + DEC
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Reslizumab 1 mg/kg iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days

Reslizumab

Diethylcarbamazine

Placebo iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days

Diethylcarbamazine

Placebo

Overall Number of Participants Analyzed 4 4
Geometric Mean (Full Range)
Unit of Measure: percent change
61
(42.7 to 104)
245.6
(175 to 372)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Reslizumab + DEC, Placebo + DEC
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Equivalence is defined as p≥0.05
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Frequency of AE's
Hide Description Adverse events during the first week of DEC treatment
Time Frame 7 days following initiation of DEC treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received DEC treatment
Arm/Group Title Reslizumab + DEC Placebo + DEC
Hide Arm/Group Description:

Reslizumab 1 mg/kg iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days

Reslizumab

Diethylcarbamazine

Placebo iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days

Diethylcarbamazine

Placebo

Overall Number of Participants Analyzed 4 4
Measure Type: Number
Unit of Measure: adverse events
29 28
3.Secondary Outcome
Title Markers of Eosinophil Activation Including Levels of Eosinophil Surface Marker Expression and Serum Levels of Eosinophil Granule Proteins
Hide Description [Not Specified]
Time Frame two years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Proportion of Subjects Who Clear Blood Microfilariae
Hide Description [Not Specified]
Time Frame 3, 7, and 28 days after initiation of treatment with DEC
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Reslizumab Placebo
Hide Arm/Group Description:

Reslizumab

Diethylcarbamazine

Placebo

Diethylcarbamazine

Overall Number of Participants Analyzed 4 4
Measure Type: Count of Participants
Unit of Measure: Participants
3 days
2
  50.0%
2
  50.0%
7 days
4
 100.0%
4
 100.0%
28 days
4
 100.0%
4
 100.0%
Time Frame 7 days
Adverse Event Reporting Description A standardized questionnaire was used to record symptoms at every visit. Laboratory assessments were performed at every visit.
 
Arm/Group Title Reslizumab + DEC Placebo + DEC
Hide Arm/Group Description

Reslizumab 1 mg/kg iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days

Reslizumab

Diethylcarbamazine

Placebo iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days

Diethylcarbamazine

Placebo

All-Cause Mortality
Reslizumab + DEC Placebo + DEC
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Reslizumab + DEC Placebo + DEC
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Reslizumab + DEC Placebo + DEC
Affected / at Risk (%) Affected / at Risk (%)
Total   4/4 (100.00%)   4/4 (100.00%) 
Gastrointestinal disorders     
Nausea   2/4 (50.00%)  1/4 (25.00%) 
Abdominal Pain   2/4 (50.00%)  1/4 (25.00%) 
General disorders     
Fatigue   1/4 (25.00%)  3/4 (75.00%) 
Headache   2/4 (50.00%)  2/4 (50.00%) 
Investigations     
LDH increased   1/4 (25.00%)  2/4 (50.00%) 
ALT increased   2/4 (50.00%)  1/4 (25.00%) 
AST increased   3/4 (75.00%)  2/4 (50.00%) 
Bilirubin increased   1/4 (25.00%)  2/4 (50.00%) 
CPK increased   2/4 (50.00%)  1/4 (25.00%) 
Hematuria   2/4 (50.00%)  1/4 (25.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia   2/4 (50.00%)  3/4 (75.00%) 
Myalgia   2/4 (50.00%)  2/4 (50.00%) 
Skin and subcutaneous tissue disorders     
Calabar swelling   2/4 (50.00%)  1/4 (25.00%) 
Pruritus   1/4 (25.00%)  2/4 (50.00%) 
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Amy Klion
Organization: NIAID/NIH
Phone: 301-435-8903
EMail: aklion@niaid.nih.gov
Layout table for additonal information
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
100101 ( Other Identifier: NIHCC )
First Submitted: April 24, 2010
First Posted: April 27, 2010
Results First Submitted: April 27, 2017
Results First Posted: June 1, 2017
Last Update Posted: December 5, 2017