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:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT03470233
Eligibility Criteria:
Inclusion Criteria
1\. Patients who are prescribed Deltyba® per prescribing information (PI) for the purpose of treatment can be included in the registry.
Exclusion Criteria
1. Patients with known hypersensitivity to Delamanid or any excipients of Deltyba®
2. Patients whose serum albumin \< 2.8 g/dL
3. Patients taking medicinal products that are strong inducers of CYP3A (e.g. carbamazepine).
4. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Sex:
ALL
Study:
NCT03470233
Study Brief:
Protocol Section:
NCT03470233