Adverse Reaction to DrugNCT04655794
Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment
An observational study of Adverse Reaction to Drug and 3HP, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Adverse Reaction to Drug, 3HP
- What is being tested?
- 3HP
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Apr 2018to 12 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The newly identified LTBI subjects who wanted to receive LTBI preventive therapy with 3HP were eligible for enrolment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Institutional Review Board Chang Gung Medical Foundation
Taipei, 333
Tsai-Yu Wang, MD, 886975368076, wang5531@gmail.com
About this study
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.
- Conditions
- Adverse Reaction to Drug, 3HP
- Being tested
- 3HP
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3HPDrug
all patients taking 3HP under directly observed preventive therapy (DOPT) program
| Study group | Role | What they receive |
|---|---|---|
| had >= grade 2 adverse reactions | Not described Receives: Drug: 3HP | |
| had <2 frade 2 adverse reactions | Not described Receives: Drug: 3HP |
What is being measured
The primary outcome is the main question the study is designed to answer.
sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)
Measured: Change from Baseline sTREM1 at 2 weeks
sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)
Measured: Change from Baseline sTREM1 at SARs
sTREM2 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)
Measured: Change from Baseline sTREM1 at 2 weeks
sTREM2 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)
Measured: Change from Baseline sTREM1 at SARs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start19 Apr 2018
- Primary completion20 Nov 2020
- Study completion12 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adverse Reaction to DrugStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655794
- Sponsor's protocol ID
- 201800081B0
- Status last verified
- Nov 2020
- First submitted
- 24 Nov 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang TY, Feng JY, Shu CC, Lee SS, Chen CY, Wei YF, Lin CB, Huang WC, Su WJ, Lin SM. Plasma Concentrations of sTREM-1 as Markers for Systemic Adverse Reactions in Subjects Treated With Weekly Rifapentine and Isoniazid for Latent Tuberculosis Infection. Front Microbiol. 2022 Mar 3;13:821066. doi: 10.3389/fmicb.2022.821066. eCollection 2022.
PubMed 35308376
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment
- ClinicalTrials.gov ID
- NCT04655794
- Acronym / sponsor ID
- 201800081B0
- Conditions
- Adverse Reaction to Drug, 3HP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 12 Feb 2021 (estimated)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| had >= grade 2 adverse reactions | – | Drug: 3HP |
| had <2 frade 2 adverse reactions | – | Drug: 3HP |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The newly identified LTBI subjects who wanted to receive LTBI preventive therapy with 3HP were eligible for enrolment.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- age less than 20 years
- pregnant women
- active TB or suspected active TB in the clinical evaluation
- severe liver disease
- ESRD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3HPall patients taking 3HP under directly observed preventive therapy (DOPT) program | Drug | had <2 frade 2 adverse reactions, had >= grade 2 adverse reactions |
Primary outcome
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
sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)
Time frame: 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
sTREM2 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)
Time frame: Change from Baseline sTREM1 at SARs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Derived from this study: PubMed 35308376Wang TY, Feng JY, Shu CC, Lee SS, Chen CY, Wei YF, Lin CB, Huang WC, Su WJ, Lin SM. Plasma Concentrations of sTREM-1 as Markers for Systemic Adverse Reactions in Subjects Treated With Weekly Rifapentine and Isoniazid for Latent Tuberculosis Infection. Front Microbiol. 2022 Mar 3;13:821066. doi: 10.3389/fmicb.2022.821066. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Adverse Reaction to Drug
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
Active, not recruiting
Introducing Electronic Alerts to Reduce Inappropriate Digoxin Prescribing in Older Adults
Drug-Related Side Effects and Adverse Reaction, Digoxin Overdose
Active, not recruitingPhase 1/2
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
Healthy Volunteer, Hypersensitivity Reactions
RecruitingObservational study
Reduction of Adverse Drug Events and Readmissions
Pharmacogenomic Testing for Medication Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Reaction to Drug and 3HP, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tsai-Yu Wang (+886975368076, wang5531@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04655794, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.