NCT04094012CompletedPhase 3
Risk of SDRs Under 3HP and 1HP Regimen for LTBI
Comparing Incidence Rate of Systemic Drug Reactions Under 3HP and 1HP Regimen for Latent Tuberculosis Infection Treatment: a Pragmatic Multicenter Randomized Control Trial
Source: ClinicalTrials.gov · Last updated 26 Dec 2023
Brief summary (registry, in English)
Successful implement of preventive therapy for subjects with latent tuberculosis infection (LTBI) is the critical step for elimination of tuberculosis (TB). The major obstacle of traditional preventive therapy is the unacceptable long treatment duration, taking isoniazid 5mg/kg daily for a total of 9 months (9H), thus seriously compromising its acceptability. With the introduction of 12-doses weekly high-dose (15 mg/kg) rifapentine plus isoniazid (3HP regimen), the completion rate of 3HP has be shown to be much higher than 9H. However, 4.9% to 9.1% of LTBI cases who received 3HP failed to complete treatment because of side effects. Systemic drug reactions (SDRs), even hypotension and shock, under 3HP treatment are higher than 9H treatment. A recent study in HIV patients demonstrated that a new short-term regimen, consisting of isoniazid 5mg/kg plus rifapentine 10mg/kg daily for one month (1HP), has a similar risk of adverse reactions as 3HP. Clinical study with head-to-head comparison between 3HP and 1HP, however, remains lacking. The prospective multicenter study is conducted to investigate whether risk of SDRs under 1HP is lower than that under 3HP. Hypothesis: 1HP has a lower incidence rate of SDRs than 3HP Objectives: 1. To compare the risk of SDRs in 1HP treatment and in 3HP treatment 2. To explore side effect profile of 1HP Methods: This multicenter randomized control trial will compare the risk of SDRs under conventional 3HP regimen (Arm 1: 3HP), and a new regimen consisting of daily rifapentine (10 mg/kg) plus isoniazid (5 mg/kg) for 1 month (Arm 2: 1HP).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 490 (actual)
- First submitted
- 3 Sept 2019
- Start date
- 24 Sept 2019
- Primary completion date
- 8 Oct 2023
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Tuberculosis
- NCT number
- NCT04094012
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 490
- From 24 Sept 2019 to the primary completion date, 8 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- concurrently using drugs with severe drug-drug interactions
Other illness
- allergic to INH, rifampin, or RPT
Age
- a life expectancy \<3 years
Other
- suspected to have active pulmonary TB because of their clinical symptoms or chest radiography findings
Who the study is looking for
- aged ≥12 years
- close contact (defined as unprotected exposure of ≥8 hours in a single day or a cumulative duration of ≥40 hours, as per the national policy of Taiwan) with patients diagnosed with acid-fast smear (AFS)-positive pulmonary TB
- diagnosed with LTBI using either a tuberculin skin test (TST) or QuantiFERON-TB Gold in-tube assay (QFT; Cellestis/Qiagen, Carnegie, Australia)
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.