Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT02430259
Eligibility Criteria:
Inclusion Criteria:
* Individuals with Silica exposure or diagnosed with silicosis;
* Age between 18 to 65 years;
* Willing to provide signed informed consent, or parental consent and participant assent.
Exclusion Criteria:
* Clinical or culture confirmed active TB;
* A history of treatment for \> 14 consecutive days with a rifamycin or \> 30 consecutive days with INH during the previous 2 years;
* A documented history of a completing an adequate course of treatment for active TB or latent TB infection;
* Allergy to Isoniazid, Rifampin, or Rifapentine;
* Human immunodeficiency virus (HIV) infection;
* History of hepatitis B/C infection or liver cirrhosis;
* Serum Aspartic transaminase (AST) or alanine transaminase (ALT) \> 2x upper limit of normal or total bilirubin \>2.5 mg/dL;
* Receiving immunosuppressants or biological agents;
* Life expectancy \<3 years;
* Mental disorder;
* Participated in other clinical trials in recent three months;
* Other conditions that investigates consider not suitable for participate.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02430259
Study Brief:
Protocol Section:
NCT02430259