Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment

Adverse Reaction to Drug Clinical Trial

Official title:

Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04655794
• Other study ID #: 201800081B0
• Status: Recruiting
• Start date: April 19, 2018
• Est. completion date: February 12, 2021

Study information

• Verified date: November 2020
• Source: Chang Gung Memorial Hospital
• Contact: Tsai-Yu Wang
• Phone: +886975368076
• Email: wang5531[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 12, 2021
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• 3HP
• Adverse Reaction to Drug
• Drug-Related Side Effects and Adverse Reactions
• Latent Tuberculosis
• Tuberculosis

Intervention

Drug:
• 3HP
all patients taking 3HP under directly observed preventive therapy (DOPT) program

Locations

Country	Name	City	State
Taiwan	Institutional Review Board Chang Gung Medical Foundation	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)		Change from Baseline sTREM1 at 2 weeks
Primary	sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)		Change from Baseline sTREM1 at SARs
Primary	sTREM2 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)		Change from Baseline sTREM1 at 2 weeks
Primary	sTREM2 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)		Change from Baseline sTREM1 at SARs