Safety and Efficacy Evaluation of <Dovprela Tablets 200 mg> by Post-marketing Surveillance
- Registration Number
- NCT06471088
- Lead Sponsor
- Viatris Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
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To be eligible for participation in this study, subjects must meet the following inclusion criteria:
- 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
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Patients falling under any of the following criteria are not included in the study:
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Cases with duplicated studies (In the event of duplicated cases, the case that has been collected first will be recognized.)
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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
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Patients with contraindications to use Bedaquiline and/or Linezolid as Dovprela Tablets are used as a combination treatment with Bedaquiline and Linezolid
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Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
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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
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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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description All Participants Dovprela This study will be conducted on subjects who were administered with Dovprela Tablets as part of their usual treatment in accordance with their local labelling. Clinical data obtained through observation will be collected from the time of the first dose of Dovprela tablet to 26 weeks of treatment and up to 6 months after the end of treatment.
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) Baseline up to approximately 6 months AE refers to undesirable and unintended signs (e.g., abnormalities in laboratory examination values), symptoms, or diseases that occur during the administration or use of drugs, etc., and it does not necessarily mean that it will have a causal relationship with the corresponding drug.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Viatris
🇰🇷Seoul, Korea, Republic of