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NCT04655794

Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment

Status unknown Last updated 7 December 2020
What this trial tests

trial testing 3HP in Adverse Reaction to Drug in 500 participants. Status unknown.

Timeline
19 April 2018
Primary endpoint
20 November 2020
12 February 2021

Quick facts

Lead sponsorChang Gung Memorial Hospital
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment500
Start date19 April 2018
Primary completion20 November 2020
Estimated completion12 February 2021
Sites1 location across Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

Chang Gung Memorial Hospital

Who can join

Adults 20 to 100, any sex, with Adverse Reaction to Drug or 3HP. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The treatment of latent TB with 3HP is an important issue for the prevention of active TB. However, significant proportion of subjects receiving 3HP had adverse reaction. The main purpose of this observation study is to identify subjects who have higher risk to develop adverse reaction. Clinical characteristics and biomarker will be used to predict adverse reaction.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Plasma Concentrations of sTREM-1 as Markers for Systemic Adverse Reactions in Subjects Treated With Weekly Rifapentine and Isoniazid for Latent Tuberculosis Infection.
    Wang TY, Feng JY, Shu CC, Lee SS, et al · · 2022 · cited 3× · PMID 35308376 · DOI 10.3389/fmicb.2022.821066

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Other trials of 3HP

Trials testing the same drug.

Other Chang Gung Memorial Hospital trials

Trials by the same sponsor.

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