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NCT06800248 | NOT YET RECRUITING | Trichuris Trichiura; Infection

Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections
Sponsor:

Swiss Tropical & Public Health Institute

Brief Summary:

This study aims to assess the efficacy and safety of emodepside compared to mebendazole in adults and adolescents infected with T. trichiura, either as single infection or co-infections with hookworm and/or A. lumbricoides.

Condition or disease

Trichuris Trichiura; Infection

Hookworm Infection

Ascaris Lumbricoides Infection

Intervention/treatment

emodepside (BAY 44-4400)

Mebendazole 100 MG

similar placebo to mebendazole

matching placebo of emodepside

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 315 participants
Masking : TRIPLE
Masking Description : Sponsor staff, Site staff
Primary Purpose : TREATMENT
Official Title : A Phase III Single-center, Randomized, Double-Blinded, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of a Single Dose of Emodepside Compared to Multiple Doses of Mebendazole in Adolescent and Adult Participants With Soil-transmitted Helminthiasis
Actual Study Start Date : 2025-08
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2026-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 12 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Male or non-pregnant (confirmed by a negative serum pregnancy test) and non-breastfeeding female participants aged 12 years and older.
  • 2. T. trichiura as a single infection or co-infection with hookworm and/or A. lumbricoides, confirmed by presence of T. trichiura eggs assessed by Kato-Katz thick smears from two stool samples (infection intensity defined as number of eggs per gram of stool (EPG): (1) light (1-999 EPG), (2) moderate to heavy (≥1000 EPG).
  • 3. A minimum infection intensity of 24 eggs per gram of stool at baseline and at least two positive slides out of the four slides assessed at baseline.
  • 4. Written informed consent signed by the participant and/or legally authorized representative(s) according to the participant's age as established per local regulations. In addition, participant's assent is required as applicable by local laws and regulations for adolescents of 12-17 years of age.
  • 5. Women of childbearing potential must agree to use an effective, culturally appropriate contraceptive measure from at least 28 days prior to first dosage for hormonal contraceptives only and for non-hormonal contraceptive measures from screening Visit 2 until End of Study Visit.
Exclusion Criteria
  • 1. Presence of any systemic illnesses, renal and/or hepatic impairment, any other acute or chronic health conditions or congenital disorders which, in the opinion of the Investigator, would make the participant unsuitable for participation in a clinical study or may interfere with the efficacy, safety, and/or pharmacokinetic (PK) evaluation of the study drug.
  • 2. Any of the following
    • 1. Platelet \<50,000/mm3
    • 2. Alanine Aminotransferase (ALT) or Serum Glutamic Pyruvic Transaminase (SGPT) \>3x upper limit of normal (ULN)
    • 3. Total bilirubin \>2xULN
    • 4. Estimated Glomerular Filtration Rate (eGFR) \<90 ml/min/1.73 m2 (adolescents) or estimated creatinine clearance (CrCl) \<90 ml/ min (adults)
    • 3. Treatment with the following anthelminthic drugs: albendazole, mebendazole, ivermectin, within 28 days before the first dose of study intervention or planned before End of Study Visit.
    • 4. Concomitant use as well as use within 14 days before the start of the first study intervention of strong CYP3A4 inhibitors or inducers, strong Pgp inducers and sensitive CYP3A4 substrates.
    • 5. Concomitant use of metronidazole from 2 days before the start of the first study intervention until 24 hours after last administration of study intervention.
    • 6. Previous assignment to a study intervention for another study planned to be administered during the period the participant is enrolled in this study (from date of informed consent to last follow-up).
    • 7. Known allergy/hypersensitivity to mebendazole and/or emodepside
Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections

Location Details

NCT06800248

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How to Participate

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Locations

Not yet recruiting

Philippines,

University of the Philippines Manila

Manila, Philippines,