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A Phase-II, Randomised, Double-blind, Parallel-group, Proof-of-concept Trial to Investigate ABBV-4083 Given for 7 or 14 Days or in Combination With Albendazole in Subjects With Onchocerca Volvulus Infection, Comprising: Part 1 to Investigate Safety, Tolerability, Efficacy for Dose-Ranging and Pharmacokinetics; Part 2 to Investigate Efficacy of Selected Doses, Safety, Tolerability and Pharmacokinetics

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Trial Profile

A Phase-II, Randomised, Double-blind, Parallel-group, Proof-of-concept Trial to Investigate ABBV-4083 Given for 7 or 14 Days or in Combination With Albendazole in Subjects With Onchocerca Volvulus Infection, Comprising: Part 1 to Investigate Safety, Tolerability, Efficacy for Dose-Ranging and Pharmacokinetics; Part 2 to Investigate Efficacy of Selected Doses, Safety, Tolerability and Pharmacokinetics

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 26 Sep 2023

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At a glance

  • Drugs Albendazole (Primary) ; Flubentylosin (Primary) ; Ivermectin (Primary)
  • Indications Onchocerciasis
  • Focus Proof of concept; Therapeutic Use
  • Sponsors AbbVie

    • Most Recent Events

    • 19 Sep 2023 Status changed from recruiting to discontinued.
    • 03 Feb 2023 Planned End Date changed from 17 Jan 2025 to 19 Dec 2025.
    • 03 Feb 2023 Planned primary completion date changed from 17 Jan 2025 to 19 Dec 2025.
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