A Phase 2 interventional study of Emodepside and Albendazole 400 mg in Trichuris Infection, sponsored by Jennifer Keiser. Not yet recruiting. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Jennifer Keiser · Phase 2, Interventional, and Treatment
The purpose of this clinical trial is to compare the efficacy and safety of emodepside with the standard treatment, albendazole, in adolescents (12 years and older) and adults infected with Trichuris incognita.
30 studies on the registry are indexed under Trichuriasis; 7 are open to participants now.
This study's planned enrollment of 100 is below the median of 315 across 27 interventional studies indexed under Trichuriasis.
Browse Trichuriasis studies →Jennifer Keiser is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Emodepside
Drug: Albendazole 400 mg
Treatment with 15 mg of emodepside
Treatment with 400mg of albendazole
Cure rate (CR) of emodepside compared to albendazole against Trichuris incognita
Trichuris incognita infection status of participants 14-21 days post-treatment assessed by Kato-Katz. CRs will be calculated as the percentage of egg-positive participants at screening who become egg-negative after treatment, for each treatment arm. Differences in CRs between the two treatments will be assessed.
Time frame: Between 14-21 days post-treatment
Egg-reduction rate (ERR) of emodepside compared to albendazole against Trichuris incognita
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric mean egg counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs. ERR is caluclated as follows: ERR = (1- (geometric mean EPG at follow-up ÷ geometric mean EPG at baseline)) x 100
Time frame: Between 14-21 days post-treatment
Safety and tolerability
Tolerability of treatments (adverse events (AEs)) will be assessed at 3- and 24- hours post-treatment and at 14 - 21 days follow up. The safety analysis will be conducted on all participants who were treated and include all available drug safety data. AEs will be evaluated descriptively as the difference between proportions of reported AEs before and after treatment.
Time frame: 3- and 24- hours post-treatment and retrospectively 14-21 days post-treatment
CR and ERR of emodepside and albendazole against Ascaris lumbricoides and hookworm in co-infected participants
If there are enough co-infections in the sample, exploratory analyses will be performed to assess the difference in cure rates and ERR for hookworm and A. lumbricoides. If there are fewer than 30 participants with co-infections of a certain species in total, the results will only be provided descriptively.
Time frame: Between 14-21 days post-treatment
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Emodepside
Jennifer Keiser