Trial · NCT04410406
Moxidectin for LF, Cote d'Ivoire (DOLF)
NCT04410406, Phase 3, Completed, Washington University School of Medicine; results first posted 2026-01-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Moxidectin for LF, Cote d'Ivoire (DOLF). Trials, record NCT04410406. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04410406
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Moxidectin for LF, Cote d'Ivoire (DOLF)
- NCT number
- NCT04410406
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 164 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Lymphatic Filariasis
- Interventions
- Ivermectin, Diethylcarbamazine, Albendazole, Moxidectin
- First posted
- 2020-06-01
- Last updated
- 2026-01-29
- Results first posted
- 2026-01-29
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clearance of Microfilaremia (IA vs. MoxA) | 12 months | The proportion of participants in IA and MoxA study arms with complete clearance of W. bancrofti microfilaremia at 12 months after treatment. |
| Primary | Clearance of Microfilaremia (IDA vs. MoxDA) | 24 months | The proportion of participants in IDA and MoxDA study arms with complete clearance of W. bancrofti microfilaremia at 24 months after treatment. |
| Secondary | Clearance of Microfilaremia | 6, 12, 24, & 36 months | The proportion of participants in each study arm with complete clearance of W. bancrofti microfilaremia at 6, 12, 24, \& 36 months after treatment. |
| Secondary | Change in Mf Counts | Assessed at Baseline, 6, 12, & 24 months; Reported at 12 and 24 months | Change in microfilariae counts (relative to baseline) at12 \& 24 months |
| Secondary | Reduction in Circulating Filarial Antigen (CFA) Counts | Assessed at Baseline, 6, 12, & 24 months; 12 and 24 months reported | Reduction in circulating filarial antigen (CFA) counts (relative to baseline) at 12 \& 24 months |
| Secondary | Inactivation of Adult Worm Nests in Male Participants Only | 6, 12, & 24 months | Inactivation of adult worm nests as assessed by scrotal ultrasound at 6, 12, and 24 months after treatment in male participants only |
| Secondary | Frequency and Severity of AEs | From baseline treatment to 7 days post-treatment | Frequency and severity of AEs during the first 7 days after treatment. |
| Secondary | Plasma Levels of Drugs/Metabolites Post Treatment | Baseline, 2, 3, 4, 6, 12, 24, & 48 hours post-treatment | Noncompartmental pharmacokinetic analyses of DEC, ABZ, ABZSO, ABZSO2, IVM and Mox concentrations will be conducted using WinNonlin (Pharsight Corporation; Cary, North Carolina, USA). Drug plasma concentrations and computed pharmacokinetic parameters will be listed by subject and summarized by drug or metabolite (geometric mean with coefficient of variation, arithmetic mean with standard deviation, minimum, maximum, number of observations). Individual and geometric mean (by time) concentrations versus time will be plotted for each treatment group on both linear and natural logarithm scales. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clearance of Microfilaremia (IA vs. MoxA) | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Clearance of Microfilaremia (IDA vs. MoxDA) | 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Clearance of Microfilaremia | 6, 12, 24, & 36 months | The number of participants analyzed at different time points differs because we were unable to follow everyone consistently in the field at all timepoints. In many cases, our participants may need to leave for farming or other seasonal obligations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Mf Counts | Assessed at Baseline, 6, 12, & 24 months; Reported at 12 and 24 months | Mean microfilaria counts | Mf/mL | MEAN |
| SECONDARY | Reduction in Circulating Filarial Antigen (CFA) Counts | Assessed at Baseline, 6, 12, & 24 months; 12 and 24 months reported | Geometric mean of circulating filarial antigen ng/mL at 12 and 24 months | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Inactivation of Adult Worm Nests in Male Participants Only | 6, 12, & 24 months | Participants with worm nest clearance (MALES ONLY) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency and Severity of AEs | From baseline treatment to 7 days post-treatment | Frequency of AEs | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Plasma Levels of Drugs/Metabolites Post Treatment | Baseline, 2, 3, 4, 6, 12, 24, & 48 hours post-treatment | Dose Normalized AUC (ng\*hr/mL) | ng*hr/mL | MEAN |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clearance of Microfilaremia (IA vs. MoxA) | IA (Ivermectin + Albendazole) | 8 | Participants | ||
| Clearance of Microfilaremia (IA vs. MoxA) | MoxA (Moxidectin + Albendazole) | 18 | Participants | ||
| Clearance of Microfilaremia (IA vs. MoxA) | IDA (Ivermectin + Diethylcarbamazine + Albendazole) | 24 | Participants | ||
| Clearance of Microfilaremia (IA vs. MoxA) | MoxDA (Moxidectin + Diethylcarbamazine + Albendazole) | 27 | Participants | ||
| Clearance of Microfilaremia (IDA vs. MoxDA) | IA (Ivermectin + Albendazole) | 13 | Participants | ||
| Clearance of Microfilaremia (IDA vs. MoxDA) | MoxA (Moxidectin + Albendazole) | 14 | Participants | ||
| Clearance of Microfilaremia (IDA vs. MoxDA) | IDA (Ivermectin + Diethylcarbamazine + Albendazole) | 20 | Participants | ||
| Clearance of Microfilaremia (IDA vs. MoxDA) | MoxDA (Moxidectin + Diethylcarbamazine + Albendazole) | 21 | Participants | ||
| Clearance of Microfilaremia | IA (Ivermectin + Albendazole) | 6 months | 8 | Participants | |
| Clearance of Microfilaremia | MoxA (Moxidectin + Albendazole) | 6 months | 15 | Participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IA (Ivermectin + Albendazole) | 41 | |
| Overall Study | STARTED | MoxA (Moxidectin + Albendazole) | 40 | |
| Overall Study | STARTED | IDA (Ivermectin + Diethylcarbamazine + Albendazole) | 41 | |
| Overall Study | STARTED | MoxDA (Moxidectin + Diethylcarbamazine + Albendazole) | 42 | |
| Overall Study | COMPLETED | IA (Ivermectin + Albendazole) | 25 | |
| Overall Study | COMPLETED | MoxA (Moxidectin + Albendazole) | 16 | |
| Overall Study | COMPLETED | IDA (Ivermectin + Diethylcarbamazine + Albendazole) | 22 | |
| Overall Study | COMPLETED | MoxDA (Moxidectin + Diethylcarbamazine + Albendazole) | 23 | |
| Overall Study | NOT COMPLETED | IA (Ivermectin + Albendazole) | 16 | |
| Overall Study | NOT COMPLETED | MoxA (Moxidectin + Albendazole) | 24 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events64
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 | Abdominal Pain | Gastrointestinal disorders | IA (Ivermectin + Albendazole) | 7 | 41 | |
| other | Abdominal Pain | Gastrointestinal disorders | MoxA (Moxidectin + Albendazole) | 2 | 40 | |
| other | Abdominal Pain | Gastrointestinal disorders | IDA (Ivermectin + Diethylcarbamazine + Albendazole) | 4 | 41 | |
| other | Abdominal Pain | Gastrointestinal disorders | MoxDA (Moxidectin + Diethylcarbamazine + Albendazole) | 2 | 42 | |
| other | Cough | General disorders | IA (Ivermectin + Albendazole) | 2 | 41 | |
| other | Cough | General disorders | MoxA (Moxidectin + Albendazole) | 0 | 40 | |
| other | Cough | General disorders | IDA (Ivermectin + Diethylcarbamazine + Albendazole) | 0 | 41 | |
| other | Cough | General disorders | MoxDA (Moxidectin + Diethylcarbamazine + Albendazole) | 2 | 42 | |
| other | Diarrhea | General disorders | IA (Ivermectin + Albendazole) | 5 | 41 | |
| other | Diarrhea | General disorders | MoxA (Moxidectin + Albendazole) | 3 | 40 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IA (Ivermectin + Albendazole) | 0 | 41 |
| Total, all-cause mortality | MoxA (Moxidectin + Albendazole) | 2 | 40 |
| Total, all-cause mortality | IDA (Ivermectin + Diethylcarbamazine + Albendazole) | 2 | 41 |
| Total, all-cause mortality | MoxDA (Moxidectin + Diethylcarbamazine + Albendazole) | 0 | 42 |
| Total, other adverse events | IA (Ivermectin + Albendazole) | 22 | 41 |
| Total, other adverse events | MoxA (Moxidectin + Albendazole) | 24 | 40 |
| Total, other adverse events | IDA (Ivermectin + Diethylcarbamazine + Albendazole) | 18 | 41 |
| Total, other adverse events | MoxDA (Moxidectin + Diethylcarbamazine + Albendazole) | 15 | 42 |
| Total, serious adverse events | IA (Ivermectin + Albendazole) | 0 | 41 |
| Total, serious adverse events | MoxA (Moxidectin + Albendazole) | 2 | 40 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers30
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04410406
GET https://conductscience.org/api/trials/v1/NCT04410406/results?page=2