Efficacy and Tolerability of Adjunct Metformin for Multibacillary Leprosy

Recruiting Phase 2 Interventional Study
Leprosy Leprosy, Multibacillary Neglected Tropical Diseases
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
166 (estimated)
Sponsor
Oxford University Clinical Research Unit Indonesia · Other
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About This Trial
This trial aims to evaluate the efficacy, tolerability and safety of adjunct metformin added to standard-of-care multi-drug therapy (MDT) in patients with multibacillary leprosy, and explore its effects on immunological endpoints. A double-blind, placebo controlled proof-of-concept trial will be performed in which patients with newly diagnosed multibacillary leprosy will be randomized (1:1) to met…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Participant is a male or female, aged ≥18 and ≤65 years. * Participant is newly diagnosed with MB leprosy and has been receiving MDT ≤ 28 days. * Participant is willing and able to give informed consent for participation in the trial. * Participant is willing to adhere to stud…
Contacts

Marlous Grijsen, MD, PhD

62-21-23599099

mgrijsen@oucru.org

CONTACT

Mutia Rahardjani, MD, MSc

62-21-23599099

mrahardjani@oucru.org

CONTACT