A Phase 2 interventional study of Emodepside in Trichuris Trichiura; Infection and Hookworm Infections, sponsored by Jennifer Keiser. Completed at 1 site in Tanzania. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-27.
Sponsored by Jennifer Keiser · Phase 2, Interventional, and Treatment
The rationale of the study is to provide evidence on the efficacy and safety of Emodepside in adults infected with Trichuris trichiura and hookworm.
30 studies on the registry are indexed under Trichuriasis; 7 are open to participants now.
This study's enrollment of 442 is above 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).
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Emodepside
Drug: Emodepside
Drug: Emodepside
Drug: Emodepside
Drug: Emodepside
Drug: Emodepside
Drug: Emodepside
Drug: Emodepside
Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or albendazole (400 mg) or placebo.
Cure rate (CR) of emodepside against Trichuris trichiura
CR will be calculated as the percentage of Trichuris trichiura egg-positive participants at baseline who become egg-negative after treatment.
Time frame: In the week between 14 and 21 days post-treatment
Cure rate (CR) of emodepside against hookworm
CR will be calculated as the percentage of hookworm egg-positive participants at baseline who become egg-negative after treatment.
Time frame: In the week between 14 and 21 days post-treatment
Geometric Mean Egg Reduction Rate (ERR) of the emodepside against Trichuris trichiura and hookworm.
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. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)\*100).
Time frame: In the week between 14 and 21 days post-treatment
CR against Ascaris lumbricoides
CR will be calculated as the percentage of Ascaris lumbricoides egg-positive participants at baseline who become egg-negative after treatment.
Time frame: In the week between 14 and 21 days post-treatment
ERR against Ascaris lumbricoides
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. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)\*100).
Time frame: In the week between 14 and 21 days post-treatment
Plan to share: No
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This study is completed, as verified in May 2022. 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