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Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment | Clinical Trials | Clareo Health

UNKNOWN

Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment

NCT04655794•Chang Gung Memorial Hospital

Summary

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.

Eligibility

Age

20 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•close contact with active TB patients
•patients with autoimmune diseases preceding biological therapy
•health-care workers
•other clinical conditions, which increased the risk of LTBI. LTBI was confirmed by QuantiFERON-TB Gold In-Tube test (QFT-GIT; Qiagen, Valencia, CA, USA) with a cut-off value of 0.35 IU/ml.

Exclusion Criteria

•age less than 20 years
•pregnant women
•active TB or suspected active TB in the clinical evaluation
•severe liver disease
•ESRD
•organ transplantation
•close contact with a multidrug-resistant TB patient
•obesity (BMI\>30 Kgw/m2) and other conditions inappropriate for participation in this study as judged by the investigators.

Locations (1)

Institutional Review Board Chang Gung Medical Foundation

Taipei, Taiwan

Key Dates

Start Date

April 19, 2018

Primary Completion Date

November 20, 2020

Completion Date

February 12, 2021

Last Updated

December 7, 2020

Enrollment

500

ESTIMATED participants

Conditions

Adverse Reaction to Drug3HP

Interventions

3HP

DRUG

Contacts

Tsai-Yu Wang

CONTACT

+886975368076 wang5531@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 7, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment

Inclusion Criteria

Exclusion Criteria

Intensive Monitoring Scheme of Lidocaine Cataplasms

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