Special drug use results surveillance for the use of SIRTURO

Special drug use results surveillance for the use of SIRTURO - SIR1L

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051506

Enrollment

200

Registered

2023-07-03

Start date

2018-05-08

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

multidrug-resistant pulmonary tuberculosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients starting SIRTURO treatment during the registration period

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
[Safety analysis] (a)Onset status of adverse drug reactions including infectious events (b)Onset status of serious adverse events (c)Influencing factors (list of onset status of adverse drug reactions/infections by background factor, etc.) (d)Onset status of electrocardiogram QT prolongedand Hepatic function disorder . [Efficacy analysis] (a)Sputum culture-negative conversion rate (b)Influencing factors (list of effectiveness by background factor, etc.) (c)Onset of tolerance mutation (d)Relapse rate	—

Measure

Time frame

[Safety analysis] (a)Onset status of adverse drug reactions including infectious events (b)Onset status of serious adverse events (c)Influencing factors (list of onset status of adverse drug reactions/infections by background factor, etc.) (d)Onset status of electrocardiogram QT prolongedand Hepatic function disorder . [Efficacy analysis] (a)Sputum culture-negative conversion rate (b)Influencing factors (list of effectiveness by background factor, etc.) (c)Onset of tolerance mutation (d)Relapse rate

—

Countries

Japan

Contacts

Public ContactManami Kamishima

Janssen pharmaceutical K.K Safety risk management Dept.

mkamishi@its.jnj.com03-4411-5530

Outcome results