An observational study in Latent Tuberculosis Infection, sponsored by Hanyang University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2017-10-18.
Sponsored by Hanyang University · Observational
Among 12 studies in Latent Tuberculosis with a site in Korea, Republic of — none open to participants now, none under way, none of them phase 3. Latent Tuberculosis · Korea, Republic of.
Among the 12 studies in Latent Tuberculosis with a site in Korea, Republic of, this one is one of 2 that started in 2017, is one of 7 observational ones, and was the 9th registered.
199 studies on the registry are indexed under Latent Tuberculosis; 48 are open to participants now.
Browse Latent Tuberculosis studies →None of the 12 studies in Latent Tuberculosis with a site in Korea, Republic of is open now.
Of the 29 Latent Tuberculosis studies recruiting now, 15 (52%) set no upper age limit and 12 (41%) stop at 75 or younger; 15 take children under 18; 7 take healthy volunteers.
This study: 19 Years and older · all sexes · no healthy volunteers.
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12 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 2 started in 2017.
This study's planned enrollment of 1,000 is above the median of 260 across 82 observational studies indexed under Latent Tuberculosis.
Median enrollment 240 across the 5 interventional studies, 1,000 across the 7 observational. Of the 6 that completed or were terminated, 1 (17%) have results posted.
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None of the 12 has an industry lead sponsor. The 8 most frequent:
Hanyang University is the lead sponsor of 52 studies on the registry; 3 are open to participants now.
Hanyang University has 3 studies filed under Latent Tuberculosis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Latent Tuberculosis with a site in Korea, Republic of, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The investigators aim to study the prevalence of adverse reactions of anti-tuberculosis (TB) drugs in latent tuberculosis infection (LTBI), and determine the risk factors of anti-TB drug-related toxicity in LTBI in Korean health care workers(HCWs).
Further study details as provided by Hanyang University Hospital
This study is prospective study of newly diagnosed LTBI in HCWs at Hanyang University Hospital, a tertiary referral hospital in South Korea, between 2017 and 2018. This study aimed to identify the prevalence of adverse reactions of treatment regimen for LTBI. The diagnosis of LTBI was made on the basis of interferon-gamma releasing assay. Information on demographic characteristics, comorbidity and treatment outcomes was collated from questionnaires. Treatment regimen for LTBI was chosen by patients' preference among 3 months of INH(isoniazid) plus RFP(rifampin), 4 months of RFP and 9 months of INH. All PTB patients were observed 2 weeks after the initiation of medication, and monthly thereafter, and were asked about any drug side effects at these visits. Serious adverse drug reaction (ADR) was defined as any severe side effect that resulted in discontinuation or change (either temporally or permanently) of anti-TB medication, and/or directly resulted in hospitalization. Drug-induced hepatitis was defined as liver transaminases more than three times higher than the upper limit of normal in the presence of symptoms such as anorexia, nausea, vomiting, or abdominal pain, or transaminases more than five times the upper limit of normal without symptoms.
Subjects diagnosed with latent tuberculosis infection (LTBI) using whole-blood interferon-r release assays in Korean health care workers.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Identified subjects with latent tuberculosis infection (LTBI) using whole-blood interferon-r release assays. All enrolled subjects were treated with one of the recommended regimens for LTBI treatment: 9 months of isoniazid, 4 months of rifampin and 3 months of isoniazid plus rifampin. Blood, urine sampling, and monitoring frequencies of adverse reactions of anti-TB drugs were performed.
The numbers of adverse drug reactions (ADR) during LTBI treatment
All events of adverse drug reactions (ADR) were reported using the clinical signs, symptoms, and liver chemistry at predefined intervals (two weeks after the initiation of anti-TB drugs, and monthly thereafter).
Time frame: one year
The numbers of severe ADR during LTBI treatment
Among all ADR, serious ADR was defined as any severe side effect that resulted in discontinuation or change (either temporally or permanently) of anti-TB drugs, and/or directly resulted in hospitalization. Drug-induced hepatitis was defined as liver transaminases more than three times higher than the upper limit of normal (γ-glutamyl transpeptidase (γ-GT) \>69 U/L; serum glutamic oxaloacetic transminase (SGOT) \>54 U/L; serum glutamic pyruvic transminase (SGPT) \>60 U/L) in the presence of symptoms such as anorexia, nausea, vomiting, or abdominal pain, or transaminases more than five times the upper limit of normal without symptoms.
Time frame: one year
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2017 (actual). Primary completion is estimated for May 2018, 11 months after the start.
Of 31 observational studies under Latent Tuberculosis, half reached primary completion within 94 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 98. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Hanyang University