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Pharmacokinetics of rifapentine and isoniazid and NAT2 and SLCO1B1 polymorphisms in pediatric Thai patients with latent tuberculosis infection

Pharmacokinetics of rifapentine and isoniazid and NAT2 and SLCO1B1 polymorphisms in pediatric Thai patients with latent tuberculosis infection

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
TCTR
Registry ID
TCTR20190423002
Enrollment
25
Registered
2019-04-23
Start date
2019-06-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Thai patients with latent tuberculosis infection rifapentine&#44

Interventions

Body weight 10&#45
14 kg&#44
received once&#45
weekly of rifapentine 300 mg and isoniazid 25 mg/kg (2&#45
11 years) or 15 mg/kg (≥12 years) (maximum&#44
900 mg) ,Body weight >14&#45
25 kg&#44
weekly of rifapentine 450 mg and isoniazid 25 mg/kg (2&#45
900 mg) ,Body weight >25&#45
32 kg&#44
weekly of rifapentine 600 mg and isoniazid 25 mg/kg (2&#45
900 mg) ,Body weight >32&#45
50 kg&#44
weekly of rifapentine 750 mg and isoniazid 25 mg/kg (2&#45

Sponsors

submitted proposal for HSRI funding of tuberculosis
Lead Sponsor
Graduate school&#44
Collaborator
Chulalongkorn University
Collaborator

Eligibility

Sex/Gender
All
Age
2 Years to 18 Years

Inclusion criteria

Inclusion criteria: -Male or female aged 2-18 years -Newly diagnosed LTBI patients  -Informed consent

Exclusion criteria

Exclusion criteria: &#45;Body weight <10 kg &#45;Acute hepatitis

Design outcomes

Primary

MeasureTime frame
mean Tmax&#44; Cmax&#44; AUC of rifapentine and isoniazid 0&#44; 1&#44; 2&#44; 4&#44; 6&#44; 8&#44; 12&#44; and 24 hours HPLC&#44; LCMS

Secondary

MeasureTime frame
genotype variants of NAT2 and SLCO1B1 predose (0 hour) Real&#45;time PCR

Countries

Thailand

Contacts

Public ContactPajaree Chariyavilaskul

Chulalongkorn University

buaying846@gmail.com022564481

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026