Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment

December 4, 2020 updated by: Chang Gung Memorial Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 333
        • Recruiting
        • Institutional Review Board Chang Gung Medical Foundation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The newly identified LTBI subjects who wanted to receive LTBI preventive therapy with 3HP were eligible for enrolment.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
had >= grade 2 adverse reactions
Drug: 3HP
all patients taking 3HP under directly observed preventive therapy (DOPT) program
had <2 frade 2 adverse reactions
Drug: 3HP
all patients taking 3HP under directly observed preventive therapy (DOPT) program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)
Time Frame: Change from Baseline sTREM1 at 2 weeks
Change from Baseline sTREM1 at 2 weeks
sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)
Time Frame: Change from Baseline sTREM1 at SARs
Change from Baseline sTREM1 at SARs
sTREM2 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)
Time Frame: Change from Baseline sTREM1 at 2 weeks
Change from Baseline sTREM1 at 2 weeks
sTREM2 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)
Time Frame: Change from Baseline sTREM1 at SARs
Change from Baseline sTREM1 at SARs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2018

Primary Completion (Actual)

November 20, 2020

Study Completion (Anticipated)

February 12, 2021

Study Registration Dates

First Submitted

November 24, 2020

First Submitted That Met QC Criteria

December 4, 2020

First Posted (Actual)

December 7, 2020

Study Record Updates

Last Update Posted (Actual)

December 7, 2020

Last Update Submitted That Met QC Criteria

December 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201800081B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adverse Reaction to Drug

Clinical Trials on 3HP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe