Development and application of iron metabolism-based model for early warning of anti-tuberculosis drug-induced liver injury

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2500115323

Enrollment

Unknown

Registered

2025-12-24

Start date

2025-03-19

Completion date

Unknown

Last updated

2026-01-05

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

Conditions

Anti-tuberculosis drug-induced liver injury

Interventions

Observational group:None

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The diagnostic criteria for tuberculosis (WS 288-2017 industry standard of the National Health Commission, and the guidelines for primary diagnosis and treatment of pulmonary tuberculosis formulated by the Infectious Diseases Group of the Respiratory Disease Branch of the Chinese Medical Association in 2018) and regularly take anti-tuberculosis drug treatment; 2. Patients with anti-tuberculosis drug-induced liver injury diagnosed in accordance with the national Guidelines for the Diagnosis and Treatment of Anti-tuberculosis Drug-induced Liver Injury (2019): ALT >= 3xULN or TBil >= 2xULN; or AST, ALP, and TBil all elevated, with at least one >= 2xULN (ULN: upper limit of normal); 3. Male or female, age >= 18 years; 4. The remaining blood routine and serum samples tested by the hospital are greater than 3 mL; if multiple retests are performed during hospitalization, serum samples from each retest will be collected; 5. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Malignancy or significant comorbidities; 2.Those who have a history of allergy to the study drug and similar drugs or have clear contraindications; 3.Women who are taking contraceptive pills or who may become pregnant; 4.Pregnant and lactating women; 5.Those who are participating in other clinical studies; 6.Samples with abnormal sample quality (e.g., severe chylemia, severe hemolysis, clots, etc.); 7.Specimens that have been frozen and thawed repeatedly;

Design outcomes

Primary

Measure	Time frame
Serum iron;Ferritin;Transferrin saturation;Total iron binding capacity;Mortality rate;Single nucleotide polymorphism (SNP);Liver function;	—

Secondary

Measure	Time frame
Inflammatory index;Drugs;Coagulation function;Blood routine index;	—

Countries

China

Contacts

Public ContactTan Shun

Chongqing Public Health Medical Center

ts86727@sina.com+86 23 65511813

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026