Safety and Efficacy Evaluation of <Dovprela Tablets 200 mg> by Post-marketing Surveillance
ConditionDovprela
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorViatris Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Cases with duplicated studies (In the event of duplicated cases, the case that has been collected first will be recognized.)
Patients with contraindications to use Bedaquiline and/or Linezolid as Dovprela Tablets are used as a combination treatment with Bedaquiline and Linezolid
Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
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
Trial population
subjects who were administered with Dovprela Tablets as part of their usual treatment in accordance with their local labelling.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Dovprela
DrugDaily dose: 200 mg
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: All Participants1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSponsors and contacts
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Source ClinicalTrials.gov