An observational study in Dovprela, sponsored by Viatris Inc.. Recruiting at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2024-06-24.
Sponsored by Viatris Inc. · Observational
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.
Viatris Inc. is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
subjects who were administered with Dovprela Tablets as part of their usual treatment in accordance with their local labelling.
To be eligible for participation in this study, subjects must meet the following inclusion criteria:
Exclusion Criteria:
Patients falling under any of the following criteria are not included in the study:
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
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.
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.
Drug: Dovprela
Daily dose: 200 mg
Number of Participants With Adverse Events (AEs)
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.
Time frame: Baseline up to approximately 6 months
Plan to share: No — All individuals directly concerned will comply with all relevant laws, including those in relation to the implementation of organizational and technical measures to ensure the protection of personal information of subjects. These actions include the deletion of the names of subjects or other directly identifiable data available in all reports, publications, or other disclosures, excluding events that are required by the corresponding law. Personal information is retained securely at the study institution in an encrypted electronic and/or written form and stored in a secure, password-protected or locked location to prevent access by unauthorized third parties.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Viatris Inc.