Actively Recruiting
Safety and Efficacy Evaluation of <Dovprela Tablets 200 mg> by Post-marketing Surveillance
Led by Viatris Inc. · Updated on 2024-06-24
100
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Dovprela Tablets (Pretomanid) is the only treatment approved for the treatment of drug-resistant tuberculosis on a wider scale. This non-interventional post-marketing surveillance (PMS) study is one of the obligations that must be followed under the Ministry of Food and Drug Safety (MFDS). In accordance with the Pharmaceutical Affairs Act and the re-examination criteria for new drugs, etc. notified by the MFDS, this study will be conducted with the purpose to collect and review required information on the safety and efficacy of drugs requiring re-examination for appropriate use. Safety and efficacy information will be provided for a minimum of 100 subjects who receive treatment in general clinical settings for a period of 4 years following approval. This survey is an open, non-comparative, non-interventional, prospective, multicenter study conducted by certified physicians (i.e., the investigator) at a Korean medical institution.
CONDITIONS
Official Title
Safety and Efficacy Evaluation of <Dovprela Tablets 200 mg> by Post-marketing Surveillance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who have been administered Dovprela Tablets according to the current local labelling after the study is initiated at the study institution
- Subjects who have consented to participate in this study by signing the data privacy statement
You will not qualify if you...
- Cases with duplicated studies (only the first collected case is recognized)
- Patients with hypersensitivity to Pretomanid or any components such as lactose monohydrate, microcrystalline cellulose, povidone, sodium starch glycolate, magnesium stearate, colloidal silicon dioxide, or sodium lauryl sulfate
- Patients with contraindications to Bedaquiline and/or Linezolid when used in combination with Dovprela Tablets
- Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Patients who are pregnant or breastfeeding or whom the investigator decides not to prescribe the drug considering risks and benefits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Viatris
Seoul, South Korea
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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