Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm (EMODEP_PEMBA)

Jennifer Keiser

Status and phase: Completed; Phase 2

Conditions: Trichuris Trichiura; Infection; Hookworm Infections

Treatments: Drug: Emodepside

Study type: Interventional

Funder types: Other

Identifiers

NCT05017194

EMODEP_PEMBA

Details and patient eligibility

About

The rationale of the study is to provide evidence on the efficacy and safety of Emodepside in adults infected with Trichuris trichiura and hookworm.

Enrollment: 442 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female adults aged between 18 and 45 years
• Written and signed informed consent
• Examined by a study physician before treatment
• Provided two stool samples at baseline
• Trichuris trichiura and hookworm EPG ≥ 48 and at least two Kato-Katz thick smears slides with more than one Trichuris trichiura and hookworm eggs

Exclusion criteria

• Pregnant or lactating and/or planning to become pregnant within three months after drug treatment
• Type 1 and/or 2 diabetes
• Psychiatric disorders
• History of ophthalmological conditions
• Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, during initial clinical assessment
• Suffers from severe anaemia (Hb < 80 g/l)
• Received anthelminthic treatment within past four weeks
• Attending other clinical trials during the study
• Received strong CYP3A4 inducers or inhibitors as well as concomitant treatments that are relevant substrate for CYP3A4 such as clarithromycin, erythromycin and rifampicin
• Received strong P-gp inhibitors as well as concomitant treatments that are relevant substrates for P-gp such as clotrimazole and ritonavir

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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442 participants in 8 patient groups, including a placebo group

Emodepside 5 mg

Experimental group

Treatment:

Drug: Emodepside

Emodepside 10 mg

Experimental group

Treatment:

Drug: Emodepside

Emodepside 15 mg

Experimental group

Treatment:

Drug: Emodepside

Emodepside 20 mg

Experimental group

Treatment:

Drug: Emodepside

Emodepside 25 mg

Experimental group

Treatment:

Drug: Emodepside

Emodepside 30 mg

Experimental group

Treatment:

Drug: Emodepside

Albendazole

Active Comparator group

Treatment:

Drug: Emodepside

Placebo

Placebo Comparator group

Treatment:

Drug: Emodepside