Safety of Administering Isoniazid to SLE Patients to Prevent TB
Recruiting
Phase 2
Phase 3
Interventional Study
Tuberculosis
Systemic Lupus Erythematosus
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 55
- Sex
- Female
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 60 (estimated)
- Sponsor
- Universitas Padjadjaran · Other
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About This Trial
Systemic Lupus Erythematosus (SLE) is a prototypical systemic autoimmune disease characterized by heterogeneity, multisystem involvement, and production of multiple autoantibodies. Clinical features can vary, from mild skin and joint involvement to severe and life-threatening conditions.
Patients with lupus are more susceptible to infections, in addition to being immunocompromised, and due to the…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
SLE patients with conditions of :
* No signs and symptoms of active TB
* Not under TB treatment
* No History of TB, malignancy, HIV, liver function test abnormality
* Not in pregnancy/lactation
* No other active infections
* Remission or low to moderate disease activity state
*…
Contacts