Trial · NCT01593722
Post-treatment Effects of Ivermectin (IVM) or Diethylcarbamazine (DEC) in Loiasis
NCT01593722, Phase 4, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2016-11-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Post-treatment Effects of Ivermectin (IVM) or Diethylcarbamazine (DEC) in Loiasis. Trials, record NCT01593722. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01593722
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Post-treatment Effects of Ivermectin (IVM) or Diethylcarbamazine (DEC) in Loiasis
- NCT number
- NCT01593722
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 155 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Loiasis
- Interventions
- Diethylcarbamazine, Ivermectin
- First posted
- 2012-05-08
- Last updated
- 2016-11-09
- Results first posted
- 2016-11-09
- Limitations and caveats
- Small number of subjects analyzed
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Peak % of Baseline Eosinophil Count Measured During the First 7 Days Post-treatment. | 7 days | |
| Secondary | The Frequency of Adverse Events | 7 days | Symptoms, signs and laboratory abnormalities occurring in the 7 days post-treatment |
| Secondary | Eosinophil Activation | 3 days | Levels of surface marker expression on eosinophils |
| Secondary | Proportion of Subjects Who Clear Microfilaremia | 14 days | |
| Other | Treatment Efficacy | 6 months | Proportion of subjects without signs of infection |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Peak % of Baseline Eosinophil Count Measured During the First 7 Days Post-treatment. | 7 days | percentage of baseline | GEOMETRIC_MEAN | |
| SECONDARY | The Frequency of Adverse Events | 7 days | events | NUMBER | |
| SECONDARY | Eosinophil Activation | 3 days | % cells expressing CD69 | GEOMETRIC_MEAN | |
| SECONDARY | Proportion of Subjects Who Clear Microfilaremia | 14 days | participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Treatment Efficacy | 6 months | Microfilarial count and symptoms | participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Peak % of Baseline Eosinophil Count Measured During the First 7 Days Post-treatment. | Diethylcarbamazine | 196 | Full Range 112 to 224 | percentage of baseline | |
| The Peak % of Baseline Eosinophil Count Measured During the First 7 Days Post-treatment. | Ivermectin | 165 | Full Range 124 to 257 | percentage of baseline | |
| The Frequency of Adverse Events | Diethylcarbamazine | 115 | events | ||
| The Frequency of Adverse Events | Ivermectin | 103 | events | ||
| Eosinophil Activation | Single Dose DEC | %CD69 expression on eosinophils at peak | 21.5 | Full Range 6.1 to 79.7 | % cells expressing CD69 |
| Eosinophil Activation | Single Dose IVM | %CD69 expression on eosinophils at peak | 21.5 | Full Range 8.4 to 94 | % cells expressing CD69 |
| Eosinophil Activation | Single Dose DEC | %CD69 expression on eosinophils at baseline | 1.7 | Full Range 0.1 to 4.2 | % cells expressing CD69 |
| Eosinophil Activation | Single Dose IVM | %CD69 expression on eosinophils at baseline | 1.5 | Full Range 0.1 to 4.6 | % cells expressing CD69 |
| Proportion of Subjects Who Clear Microfilaremia | Diethylcarbamazine | 3 | participants | ||
| Proportion of Subjects Who Clear Microfilaremia | Ivermectin | 0 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Single Dose DEC | 6 | |
| Overall Study | STARTED | Single Dose IVM | 6 | |
| Overall Study | COMPLETED | Single Dose DEC | 6 | |
| Overall Study | COMPLETED | Single Dose IVM | 6 | |
| Overall Study | NOT COMPLETED | Single Dose DEC | 0 | |
| Overall Study | NOT COMPLETED | Single Dose IVM | 0 |
Source ClinicalTrials.gov
Adverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Calabar swelling | Skin and subcutaneous tissue disorders | Diethylcarbamazine | 3 | 6 | |
| other | Calabar swelling | Skin and subcutaneous tissue disorders | Ivermectin | 2 | 6 | |
| other | Headache | Nervous system disorders | Diethylcarbamazine | 4 | 6 | |
| other | Headache | Nervous system disorders | Ivermectin | 4 | 6 | |
| other | Eyeworm | Infections and infestations | Diethylcarbamazine | 1 | 6 | |
| other | Eyeworm | Infections and infestations | Ivermectin | 2 | 6 | |
| other | Blurry vision | Eye disorders | Diethylcarbamazine | 3 | 6 | |
| other | Blurry vision | Eye disorders | Ivermectin | 1 | 6 | |
| other | Paresthesia | Nervous system disorders | Diethylcarbamazine | 1 | 6 | |
| other | Paresthesia | Nervous system disorders | Ivermectin | 1 | 6 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Diethylcarbamazine | ||
| Total, all-cause mortality | Ivermectin | ||
| Total, other adverse events | Diethylcarbamazine | 6 | 6 |
| Total, other adverse events | Ivermectin | 6 | 6 |
| Total, serious adverse events | Diethylcarbamazine | 0 | 6 |
| Total, serious adverse events | Ivermectin | 0 | 6 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Diethylcarbamazine vs Ivermectin: Proportion of Subjects Who Clear Microfilaremia | Trial comparisons |
| Diethylcarbamazine vs Ivermectin: Treatment Efficacy | Trial comparisons |
| Diethylcarbamazine vs Ivermectin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01593722
GET https://conductscience.org/api/trials/v1/NCT01593722/events?page=2