Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment

• Conditions: Adverse Reaction to Drug; 3HP
• Interventions: Drug: 3HP

• Registration Number: NCT04655794
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-19
• Status Verified: 2020-11
• Primary Completion: 2020-11-20
• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-12-04
• Last Update Submitted: 2020-12-04
• Study First Posted: 2020-12-07
• Last Update Posted: 2020-12-07
• Study Completion: 2021-02-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
had <2 frade 2 adverse reactions	3HP	-
had >= grade 2 adverse reactions	3HP	-

Primary Outcome Measures

Name	Time	Method
sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)	Change from Baseline sTREM1 at SARs
sTREM2 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)	Change from Baseline sTREM1 at SARs

Trial Locations

Locations (1)

Institutional Review Board Chang Gung Medical Foundation; 🇨🇳 Taipei, Taiwan