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Safety and Efficacy of IDA for Onchocerciasis

NCT04188301 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2024-06-04

Study results available
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Summary

This DOLF study will investigate the safety and effectiveness of IDA treatment in persons with onchocerciasis when it is administered after pre-treatment with ivermectin to clear or greatly reduce microfilariae from the skin and eyes.

Conditions

  • Onchocerciasis

Interventions

DRUG

IVM w/ ALB

Participants will be given a single dose of oral IVM (150 µg/kg) plus ALB (400 mg) (IVM/ALB)

DRUG

Single dose of IDA

Participants will be given a single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)

DRUG

Three daily doses of IDA

Participants will be given one daily dose for 3 days of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)

Sponsors & Collaborators

  • Case Western Reserve University

    collaborator OTHER

  • University of Health and Allied Sciences

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Gary Weil, MD · Washington University School of Medicine

  • Christopher King, MD, PhD · Case Western Reserve University

  • Nicholas Opoku, MB, CHB, MSC · University of Health and Allied Sciences, Hohoe, Ghana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-06
Primary Completion
2022-03-14
Completion
2022-06-01
FDA Drug
Yes

Countries

  • Ghana

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04188301 on ClinicalTrials.gov