Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Hookworm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-16

Study Completion Date

2023-04-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To compare the efficacy and safety of emodepside to that of albendazole (Zentel®) in participants aged 12-60, inclusive, infected with hookworm.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05017194

Trichuris Trichiura; Infection Hookworm Infections

COMPLETED PHASE2

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

NCT06736691

Trichuris Trichiura; Infection Hookworm Infection Ascaris Lumbricoides Infection

ENROLLING_BY_INVITATION PHASE3

Efficacy and Safety of a Multi-dose Regimen of Mebendazole Against Hookworm in Children

NCT03245398

Hookworm

COMPLETED PHASE4

Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris Trichiura

NCT03501251

Trichuris Trichiura; Infection

COMPLETED PHASE2

Efficacy and Safety of Emodepside in Adults Infected With Strongyloidiasis Stercoralis

NCT06373835

Strongyloides Stercoralis Infection Strongyloidiasis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hookworm Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Emodepside 30 mg

Group Type EXPERIMENTAL

Emodepside

Intervention Type DRUG

Treatment with Emodepside 30 mg

Albendazole 400 mg

Group Type ACTIVE_COMPARATOR

Albendazole 400mg

Intervention Type DRUG

Treatment with Albendazole 400 mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Emodepside

Treatment with Emodepside 30 mg

Intervention Type DRUG

Albendazole 400mg

Treatment with Albendazole 400 mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female adults aged between 12 and 60 years;
* Written and signed informed consent;
* Was examined by a study physician before treatment;
* Provided two stool samples at baseline;
* Hookworm EPG \> 48 and at least two Kato-Katz thick smears slides with more than one 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.
* Participated in stage I trials of this protocol

Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes