Evaluation of Dovprela Tablets for drug-resistant tuberculosis
Safety and Efficacy Evaluation of <Dovprela Tablets 200 mg> by Post-marketing Surveillance
This study is testing if Dovprela Tablets are safe and effective for people with drug-resistant tuberculosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Viatris Inc. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06471088 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the safety and efficacy of Dovprela Tablets (Pretomanid), the only treatment approved for drug-resistant tuberculosis. It is a non-interventional post-marketing surveillance study mandated by the Ministry of Food and Drug Safety in Korea. The study aims to collect safety and efficacy data from at least 100 subjects over a four-year period following the drug's approval. Certified physicians will conduct the study in general clinical settings across multiple centers.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have been prescribed Dovprela Tablets in accordance with local labeling.
Not a fit: Patients with hypersensitivity to Pretomanid or its components, or those with contraindications to Bedaquiline and/or Linezolid will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of Dovprela for patients with drug-resistant tuberculosis.
How similar studies have performed: Other studies on post-marketing surveillance of tuberculosis treatments have shown success in providing critical safety and efficacy data, making this approach well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* To be eligible for participation in this study, subjects must meet the following inclusion criteria:
1. Patients who have been administered Dovprela Tablets according to the current local labelling after the study is initiated at the study institution
2. Subjects who have consented to participate in this study by signing the data privacy statement
Exclusion Criteria:
* Patients falling under any of the following criteria are not included in the study:
1. Cases with duplicated studies (In the event of duplicated cases, the case that has been collected first will be recognized.)
2. Patients with hypersensitivity to active substance (Pretomanid) or components. The list of components is as follows:
\*Components: Lactose monohydrate, microcrystalline cellulose, povidone, sodium starch glycolate, magnesium stearate, colloidal silicon dioxide, sodium lauryl sulfate
3. Patients with contraindications to use Bedaquiline and/or Linezolid as Dovprela Tablets are used as a combination treatment with Bedaquiline and Linezolid
4. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
5. Other patients whom the investigator decides not to prescribe under general practice, considering the overall balance of risks and benefits, such as those who are pregnant or breastfeeding
If data of the subjects that have not been used within the scope of permitted items is collected, it shall be analysed as a separate item.
Where this trial is running
Seoul
- Viatris — Seoul, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.