Anti-TB therapy following drug-induced liver injury (TB-DILI)

Reintroduction of anti-tuberculosis therapy following drug-induced liver injury: a randomised controlled trial (TB-DILI)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN92067975

Enrollment

350

Registered

2022-08-25

Start date

2022-08-01

Completion date

Unknown

Last updated

2026-07-13

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

Conditions

Drug induced liver injury in patients receiving tuberculosis treatment. Respiratory

Interventions

Eligible patients will be individually randomised on a 1:1 ratio to one of the treatment groups using an online randomisation system developed and maintained by the NCTU. Intervention Sequential full

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Aged =18 years 2. Experienced DILI with standard 4-drug ATT for active pulmonary or extra-pulmonary TB 3. Medically suitable 4. for re-introduction of standard 4-drug ATT

Exclusion criteria

Exclusion criteria: 1. Requirement for alternative ATT 2. Unable to provide written informed consent

Design outcomes

Primary

Measure	Time frame
DILI recurrence within 12 months following randomisation. DILI recurrence could occur at any timepoint during the treatment period. Sites will perform routine clinical assessments to determine a DILI this data will then be submitted for adjudication.	—

Secondary

Measure	Time frame
1. Severity of DILI recurrence measured using routine clinical assessments at 12 months 2. Physician rated clinical cure at end of treatment (EoT) 3. Clinical cure at 12 months 4. Total number of days on ATT at EoT 5. ATT adherence at EoT 6. Adverse event rate at EoT or at 12 months whichever is sooner 7. Mortality at 12 months 8. Quality of life assessed by EQ-5D-5L and healthcare resource use at 12 months	—

Measure

Time frame

1. Severity of DILI recurrence measured using routine clinical assessments at 12 months 2. Physician rated clinical cure at end of treatment (EoT) 3. Clinical cure at 12 months 4. Total number of days on ATT at EoT 5. ATT adherence at EoT 6. Adverse event rate at EoT or at 12 months whichever is sooner 7. Mortality at 12 months 8. Quality of life assessed by EQ-5D-5L and healthcare resource use at 12 months

—

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026